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

NCT05991349 | Completed Phase 1

• 1 other identifier: CIBI129A101
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

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

  24 months

• Number of subjects with clinically significant changes in physical examination results

  Clinically significant abnormal physical examination findings reported by the investigator.

  24 months

• Number of subjects with clinically significant changes in vital signs

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

  24 months

• MTD or RP2D of IBI129

  Number of subjects with dose-limiting toxicities (DLTs)

  12 months

Secondary Outcomes (13)

• Plasma concentration (Cmax) of IBI129

  12 months

• Area under the curve (AUC) of IBI129

  12 months

• Time to maximum concentration (Tmax) of IBI129

  12 months

• Clearance (CL) of IBI129

  12 months

• Volume of distribution (V) of IBI129

  12 months

Study Arms (1)

IBI129

EXPERIMENTAL

IBI129

Drug: IBI129

Interventions

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.

IBI129

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (7)

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St George private Hospital

Kogarah, New South Wales, 2217, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Tianjin Medical university cancer institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: March 12, 2024
• Primary Completion: November 30, 2024
• Study Completion: May 31, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CN (4)