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NCT Number: NCT05156866

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced solid tumor
  • Measurable disease, per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function

Exclusion criteria

  • Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
  • Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC
  • Progressive or symptomatic brain metastases
  • Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • History of significant cardiac disease
  • History of myelodysplastic syndrome (MDS) or AML
  • History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
  • If female, is pregnant or breastfeeding

Treatment and study plan

TORL-2-307-ADC

Drug

antibody drug conjugate

Primary outcomes

  1. Incidence and severity of adverse events and serious adverse events

    Time frame: up to 2 years

    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

  2. Maximum Tolerated Dose (MTD)

    Time frame: 28 Days

    Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

  3. Recommended Phase 2 Dose (RP2D)

    Time frame: up to 2 years

    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 2 years

    Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

  2. Duration of Response (DOR)

    Time frame: up to 2 years

    Time from CR or PR to objective disease progression or death to any cause

  3. Progression Free Survival (PFS)

    Time frame: up to 2 years

    PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause

  4. Time to Response (TTR)

    Time frame: up to 2 years

    Time from start of treatment to complete response or partial response

  5. 1 Year Overall Survival (1YOS)

    Time frame: 1 year

    Proportion of participants alive at 1 year from the start of treatment to death from any cause

  6. 2 Year Overall Survival (2YOS)

    Time frame: 2 years

    Proportion of participants alive at 2 years from the start of treatment to death from any cause

  7. Number of anti-drug antibody (ADA) Positive Participants

    Time frame: up to 2 years

    Immunogenicity will be measured by the number of participants that are ADA positive.

  8. Maximum Serum Concentration of TORL-2-307-ADC (Cmax)

    Time frame: 21 days

    PK assessment

  9. Minimum Serum Concentration of TORL-2-307-ADC (Cmin)

    Time frame: 21 days

    PK assessment

  10. Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)

    Time frame: 63 days

    PK assessment

  11. Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)

    Time frame: 63 days

    PK assessment

  12. Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)

    Time frame: 21 days

    PK assessment

  13. Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)

    Time frame: 21 days

    PK Assessment

  14. Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)

    Time frame: 63 days

    PK Assessment

  15. Terminal Half-life (t1/2) of Serum TORL-2-307-ADC

    Time frame: 63 days

    PK Assessment

  16. Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-ADC

    Time frame: 21 days

    PK Assessment

  17. Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-ADC

    Time frame: 63 days

    PK Assessment

  18. Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC

    Time frame: 63 days

    PK Assessment

  19. Clearance (CL) of TORL-2-307-ADC

    Time frame: 63 days

    PK Assessment

  20. Accumulation ratio (Rac) of TORL-2-307-ADC

    Time frame: 63 days

    PK Assessment

Sponsors and collaborators

Lead sponsor

TORL Biotherapeutics, LLC

Industry

Collaborators

  • Translational Research in Oncology

Registry information

Official study title

A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 14, 2021
Registry last updated
Jan 13, 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.

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