Status:
COMPLETED
A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 phas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05991349
Start Date
March 12 2024
End Date
May 31 2025
Last Update
November 25 2025
Active Locations (7)
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1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
2
St George private Hospital
Kogarah, New South Wales, Australia, 2217
3
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
4
Hubei Cancer Hospital
Wuhan, Hubei, China