Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05278546

A Study of ILB2109 in Patients With Advanced Solid Malignancies

This is a multicenter, open-label, phase Ia study to evaluate the safety, tolerability and preliminary efficacy of ILB2109, a A2a receptor antagonist, in patients with locally advanced or metastatic solid malignancies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong Cancer Hospital and Institute, Jinan, Shandong, China

Loading trial locations.

About this study

This is a two-part study consists of dose escalation and dose expansion. The dose escalation part adopts a 3+3 protocol design and consists of 5 cohorts. Based on the data obtained from the escalation study, selected cohorts will be expanded to further investigate the safety and efficacy of the study drug. The escalation part consists of a single-dose cycle (Cycle 0) followed by multiple-dose cycles (Cycle 1 and above). Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytological confirmed, solid, malignant tumor that is refractory to standard therapy or for which no standard of care regimen currently exists;
  • At least one assessable tumor lesion according to RECIST v1.1 in dose escalation part of the study ; At least one measurable tumor lesion according to RECIST v1.1 in dose expansion part of the study;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Major organ functions are normal, meets pre-specified lab requirements;
  • Females of reproductive age must have a negative serological hCG test during the screening period;
  • Subjects of reproductive age (both male and female) must agree to use contraceptive methods from signing Informed Consent to 90 days post the last dose;

Exclusion criteria

  • Has received any investigational medicinal product or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment;
  • Unable to take medication orally, or has impaired GI function;
  • Has received systemic glucocorticoids (prednisone>10 mg/ day or an equivalent dose of another drug of the same class) or other immunosuppressants within 14 days prior to the first dose of study treatment;
  • Has received live, attenuated vaccines within 4 weeks prior to the first dose of study treatment;
  • Has active infection that requires intravenous anti-infective therapy;
  • History of HIV infection, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
  • History of serious cardiovascular and cerebrovascular diseases;
  • History of adverse effect from previous antineoplastic therapy that has not returned to CTCAE grade 5.0 ≤1;
  • Cerebral parenchymal or meningeal metastasis;
  • History of ≥ Grade 3 irAE or ≥ Grade 2 myocarditis from previous immune therapy;

Treatment and study plan

ILB2109

Drug

ILB2109 tablets by mouth once per day at dosages prespecified by the protocol. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Primary outcomes

  1. The Incidence of DLTs

    Time frame: At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)

    The incidence rate of Dose Limiting Toxicities (DLTs)

  2. MTD

    Time frame: 30 Months

    Determining the maximum tolerated dose (MTD) for subsequent studies

  3. RD

    Time frame: 30 Months

    Determining the Recommended Dose (RD) for subsequent studies

Secondary outcomes

  1. Safety Outcomes

    Time frame: From Informed Consent to 28 days after the last dose, expected follow-up period 6 months

    Determining the incidence rate, type and severity of Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and lab abnormalities (hematology and major organ function lab tests) based on NCI-CTCAE 5.0;

  2. Objective Response Rate (ORR)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    n tumor treatment, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain period of time. It includes the proportion of patients with complete remission (CR) and partial remission (PR) to the total number of evaluable cases.

  3. Progression Free Survival (PFS)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    The time from randomization of patients to the onset of disease progression.

  4. Overall Survival (OS)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    The time from randomization to death for any reason

  5. 1-Year OS

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    The probability of a survival time of 1 year after treatment for this disease

  6. Time To Response (TTR)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    Time from the start of treatment to the first objective tumor response

  7. Duration Of Response (DOR)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    The time from response to progression/death

  8. Clinical Benefit Response (CBR)

    Time frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

    The total percentage of patients who achieved a complete response, partial response, or had stable disease for 6 months or more.

  9. Maximum Plasma Concentration (Cmax)

    Time frame: Blood samples will be collected at pre-specified time points in Cycles 0, 1 and 2 (Cycle 0 is 3 days, Cycles 1&2 each is 21 days)

    Characterize the single-dose and multiple-dose plasma concentration of ILB2109

  10. Area Under the plasma drug concentration-time Curve (AUC)

    Time frame: Blood samples will be collected at pre-specified time points in Cycles 0, 1 and 2 (Cycle 0 is 3 days, Cycles 1&2 each is 21 days)

    Characterize the single-dose and multiple-dose plasma concentration of ILB2109

Other outcomes

  1. Plasma Concentration of Downstream Signaling Protein

    Time frame: Blood samples will be collected at pre-specified time points in Cycles 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)

    Characterize the relationship between the plasma concentration of ILB2109 and the level of a downstream signaling protein to evaluate the pharmacodynamics of ILB2109.

Sponsors and collaborators

Lead sponsor

Innolake Biopharm

Industry

Collaborators

  • Shandong Cancer Hospital and Institute
  • Shanghai East Hospital

Registry information

Official study title

A Phase Ia, Multicenter, Open-label Study of ILB2109 in Patients With Advanced Solid Malignancies

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 14, 2022
Registry last updated
Nov 12, 2024

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.