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Completed

NCT Number: NCT05991349

A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  • At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
  • Male or female subjects ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • Anticipated life expectancy of ≥ 12 weeks;
  • Adequate bone marrow and organ function

Exclusion criteria

  • Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
  • Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter.
  • Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
  • Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
  • Known symptomatic central nervous system (CNS) metastases.

Treatment and study plan

IBI129

Drug

Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: 24 months

    Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria

  2. Number of subjects with clinically significant changes in physical examination results

    Time frame: 24 months

    Clinically significant abnormal physical examination findings reported by the investigator.

  3. Number of subjects with clinically significant changes in vital signs

    Time frame: 24 months

    Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

  4. MTD or RP2D of IBI129

    Time frame: 12 months

    Number of subjects with dose-limiting toxicities (DLTs)

Secondary outcomes

  1. Plasma concentration (Cmax) of IBI129

    Time frame: 12 months

    Plasma concentration of IBI129 for single and multiple doses.

  2. Area under the curve (AUC) of IBI129

    Time frame: 12 months

    AUC of IBI129 for single and multiple doses.

  3. Time to maximum concentration (Tmax) of IBI129

    Time frame: 12 months

    Tmax of IBI129 for single and multiple doses.

  4. Clearance (CL) of IBI129

    Time frame: 12 months

    Clearance of IBI129 from the plasma

  5. Volume of distribution (V) of IBI129

    Time frame: 12 months

    Apparent volume of distribution of IBI129.

  6. Half-life (T1/2) of IBI129

    Time frame: 12 months

    T1/2 of IBI129 for single and multiple doses.

  7. Immunogenicity of IBI129

    Time frame: 12 months

    Incidence of anti-drug (IBI129) antibody

  8. Objective response rate (ORR)

    Time frame: 24 months

    ORR as evaluated per the RECIST v1.1 criteria

  9. Duration of response (DoR)

    Time frame: 24 months

    DoR as evaluated per the RECIST v1.1 criteria

  10. Disease control rate (DCR)

    Time frame: 24 months

    DCR as evaluated per the RECIST v1.1 criteria

  11. Time to response (TTR)

    Time frame: 24 months

    TTR as evaluated per the RECIST v1.1 criteria

  12. Progression free survival (PFS)

    Time frame: 24 months

    PFS as evaluated per the RECIST v1.1 criteria

  13. Overall survival (OS)

    Time frame: 24 months

    Overall survival.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Jun 24, 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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