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

Solid Tumor Clinical Trial

Official title:

A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991349
• Other study ID #: CIBI129A101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 12, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Serena Dong
• Phone: 051269566088
• Email: suhua.dong[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
Australia	St George private Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events	Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria	24 months
Primary	Number of subjects with clinically significant changes in physical examination results	Clinically significant abnormal physical examination findings reported by the investigator.	24 months
Primary	Number of subjects with clinically significant changes in vital signs	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure	24 months
Primary	MTD or RP2D of IBI129	Number of subjects with dose-limiting toxicities (DLTs)	12 months
Secondary	Plasma concentration (Cmax) of IBI129	Plasma concentration of IBI129 for single and multiple doses.	12 months
Secondary	Area under the curve (AUC) of IBI129	AUC of IBI129 for single and multiple doses.	12 months
Secondary	Time to maximum concentration (Tmax) of IBI129	Tmax of IBI129 for single and multiple doses.	12 months
Secondary	Clearance (CL) of IBI129	Clearance of IBI129 from the plasma	12 months
Secondary	Volume of distribution (V) of IBI129	Apparent volume of distribution of IBI129.	12 months
Secondary	Half-life (T1/2) of IBI129	T1/2 of IBI129 for single and multiple doses.	12 months
Secondary	Immunogenicity of IBI129	Incidence of anti-drug (IBI129) antibody	12 months
Secondary	Objective response rate (ORR)	ORR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Duration of response (DoR)	DoR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Disease control rate (DCR)	DCR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Time to response (TTR)	TTR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Progression free survival (PFS)	PFS as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Overall survival (OS)	Overall survival.	24 months