Skip to main content
OpenTrials
Completed

NCT Number: NCT05052268

XTX202 in Patients With Advanced Solid Tumors

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC San Diego Moores Cancer Center, La Jolla, California, United States

Loading trial locations.

About this study

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors.

Phase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.

Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Disease Criteria
  • Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available
  • Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
  • Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies
  • Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.
  • ECOG performance status of 0 or 1
  • Adequate organ function
  • Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.

Exclusion criteria

  • Received prior treatment with IL-2 therapy
  • History of clinically significant pulmonary disease
  • History of clinically significant cardiovascular disease
  • Has a diagnosis of immunodeficiency
  • Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
  • Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

Treatment and study plan

XTX202

Drug

XTX202 Monotherapy

Primary outcomes

  1. Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)

    Time frame: Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)

    All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following:

    • Any treatment-related Grade ≥ 3 toxicity
    • Any Grade febrile neutropenia
    • The following nonhematologic exceptions:
    • Grade 3 nausea or vomiting lasting < 3 days
    • Grade 3 fatigue lasting < 7 days
    • Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days

  2. Incidence of Treatment-emergent Adverse Events (Phase 1 Only)

    Time frame: Up to 24 months

    Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.

  3. Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only)

    Time frame: Up to 24 months

    Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1.

    In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  4. Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry

    Time frame: Up to 24 months

    Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.

  5. Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology

    Time frame: up to 24 months

    Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.

  6. Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function

    Time frame: Up to 24 months

    Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.

  7. Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation

    Time frame: Up to 24 months

    Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value

Secondary outcomes

  1. Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)

    Time frame: Up to 24 months

    Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1.

  2. Duration of Response (DOR) (Phase 2 Only)

    Time frame: Up to 24 months

    Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.

  3. Disease Control Rate (Phase 2 Only)

    Time frame: Up to 24 months

    Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment.

    In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  4. Overall Survival (OS) (Phase 2 Only)

    Time frame: Up to 24 months

    OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive.

    In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group

  5. Progression-free Survival (PFS) (Phase 2 Only)

    Time frame: Up to 24 months

    PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.

    In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group

  6. Incidence of Treatment-emergent Adverse Events (Phase 2 Only)

    Time frame: Up to 24 months

    Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0.

  7. Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology

    Time frame: Up to 24 months

    Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.

  8. Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry

    Time frame: Up to 24 months

    Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.

  9. Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function

    Time frame: Up to 24 months

    Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.

  10. Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation

    Time frame: Up to 24 months

    Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.

  11. Plasma Concentrations of Total XTX202

    Time frame: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1

    Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  12. Plasma Concentrations of Intact XTX202

    Time frame: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1

    Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  13. Total XTX202 Plasma Trough Concentration

    Time frame: From Cycle 1 to up to Cycle 18 (21 days per cycle)

    Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group

  14. Intact XTX202 Plasma Trough Concentration

    Time frame: from Cycle 1 to up to Cycle 18 (21 days per cycle)

    Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  15. Maximum Observed Plasma Concentration (Cmax) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Cmax following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  16. Maximum Observed Plasma Concentration (Cmax) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Cmax following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  17. Time of Maximum Observed Concentration (Tmax) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  18. Time of Maximum Observed Concentration (Tmax) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  19. Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  20. Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  21. Half-life (T1/2) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  22. Half-life (T1/2) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  23. Systemic Clearance (CL) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  24. Systemic Clearance (CL) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  25. Volume of Distribution (Vd) of Total XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  26. Volume of Distribution (Vd) of Intact XTX202

    Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1

    Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202.

    In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  27. Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)

    Time frame: from Cycle 1 Day 1 to up to 24 months

    Overall ADA Incidence Following a Single IV Administration of XTX202

    In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

  28. Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)

    Time frame: From Cycle 1 Day 1 to up to 24 months

    Overall ADA Incidence Following a Single IV Administration of XTX202.

    In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.

    In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.

Sponsors and collaborators

Lead sponsor

Xilio Development, Inc.

Industry

Registry information

Official study title

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.