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Trial Title:
A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05991349
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI129
Description:
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.
Arm group label:
IBI129
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 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1.;
3. Male or female subjects ≥ 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
5. Anticipated life expectancy of ≥ 12 weeks;
6. Adequate bone marrow and organ function
Exclusion Criteria:
1. Participate in any other interventional clinical research except observational
(non-interventional) study or in the follow-up phase of the interventional study;
2. 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.
3. Progressed refractory to an antibody drug conjugate that consists of an exatecan
derivative that is a topoisomerase I inhibitor.
4. 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;
5. Known symptomatic central nervous system (CNS) metastases.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St George private Hospital
Address:
City:
Sydney
Zip:
2217
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Paul Souza
Phone:
+612 9598 5022
Email:
P.DeSouza@westernsydney.edu.au
Start date:
March 12, 2024
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991349
