IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumors
• Interventions: Drug: IBI334 E; Drug: IBI334 D; Drug: IBI334 C; Drug: IBI334 B; Drug: IBI334 A; Drug: IBI334 F

• Registration Number: NCT05774873
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-08-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-10-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI334 E	IBI334 E	-
IBI334 D	IBI334 D	-
IBI334 C	IBI334 C	-
IBI334 B	IBI334 B	-
IBI334 A	IBI334 A	-
IBI334 F	IBI334 F	-

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events	Up to 60 days post last dose	Number of patients who experienced a treatment related AEs from the first dose until 60 days after the last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)	Up to 28 days following first dose	To evaluate the safety and tolerability of IBI334

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 60 days post last dose	Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response(PR) assessed per RECIST v1.1 criteria .
Duration of response (DoR)	Up to 60 days post last dose	For subjects with CR or PR, duration of response(DoR) is the time from the first documented CR or PR to disease progression or death assessed per RECIST V1.1 criteria.
Overall survival (OS)	Up to 60 days post last dose	Time from randomization to death of the subject due to any cause.
Disease control rate (DCR)	Up to 60 days post last dose	Disease control rate (DCR) is the percentage of CR plus PR Plus stable disease (SD) assessed per RECIST v1.1 criteria.
Time to Response (TTR)	Up to 60 days post last dose	For subjects with CR or PR, time to response(TTR) is the time from first dose of study drugs to the first documented CR or PR assessed per RECIST v1.1 criteria.
Progression-free survival (PFS)	Up to 60 days post last dose	Time from randomization to first documented disease progression (radiographic) assessed by investigator per RECIST v1.1 criteria or death due to any cause.

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Waratah, New South Wales, Australia