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

A Phase 1/2 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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: IBI129

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Kogarah, New South Wales, Australia, 2217
      • St George Private Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
• China
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI129	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration (Cmax) of IBI129	Plasma concentration of IBI129 for single and multiple doses.	12 months
Area under the curve (AUC) of IBI129	AUC of IBI129 for single and multiple doses.	12 months
Time to maximum concentration (Tmax) of IBI129	Tmax of IBI129 for single and multiple doses.	12 months
Clearance (CL) of IBI129	Clearance of IBI129 from the plasma	12 months
Volume of distribution (V) of IBI129	Apparent volume of distribution of IBI129.	12 months
Half-life (T1/2) of IBI129	T1/2 of IBI129 for single and multiple doses.	12 months
Immunogenicity of IBI129	Incidence of anti-drug (IBI129) antibody	12 months
Objective response rate (ORR)	ORR as evaluated per the RECIST v1.1 criteria	24 months
Duration of response (DoR)	DoR as evaluated per the RECIST v1.1 criteria	24 months
Disease control rate (DCR)	DCR as evaluated per the RECIST v1.1 criteria	24 months
Time to response (TTR)	TTR as evaluated per the RECIST v1.1 criteria	24 months
Progression free survival (PFS)	PFS as evaluated per the RECIST v1.1 criteria	24 months
Overall survival (OS)	Overall survival.	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI129A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No