A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

Phase 1

• Conditions: Solid Tumor
• Interventions: Drug: IBI325+Sintilimab

• Registration Number: NCT05246995
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Study Start: 2022-03-23
• Primary Completion: 2023-03-23
• Study Completion: 2023-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI325 and Sintilimab combination does-escalation	IBI325+Sintilimab	-

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment related AEs	Up to 90 days post last dose	Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Number of patients with DLT	42 days post first dose	Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose

Secondary Outcome Measures

Name	Time	Method
Number of patients with response	Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first	Number of patients with response per RECIST 1.1

Trial Locations

Locations (1)

Shandong Province Cancer Hospital; 🇨🇳 Jinan, Shandong, China