A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: IBI130

• Registration Number: NCT05923008
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Status Verified: 2023-11
• Study Start: 2023-11-14
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-11-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

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. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function

Exclusion Criteria

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an 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. 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;
4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI130	IBI130	IBI130

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 30 days post last dose	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	Time from first dose to best response to treatment, assessed up to 3 years	ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
duration of response(DoR)	Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years	For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
overall survival (OS)	Time from first dose to death, assessed up to 3 years	Time from the date of the first dose to death of the subject due to any cause

Trial Locations

Locations (1)

Sunshine Coast University; 🇦🇺 Birtinya, Queensland, Australia