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

NCT ID: NCT05991349

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-05-31

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 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

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI129

IBI129

Group Type: EXPERIMENTAL

IBI129

Intervention Type: 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.

Interventions

IBI129

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

St George private Hospital

Kogarah, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Hubei Cancer Hospital

Wuhan, Hubei, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shandong Cancer Hospital

Jinan, Shandong, China

Tianjin Medical university cancer institute & Hospital

Tianjin, Tianjin Municipality, China

Countries

Australia; China

Other Identifiers

CIBI129A101

Identifier Type: -

Identifier Source: org_study_id