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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: IBI325 + sintilimab; Drug: IBI325

• Registration Number: NCT05119998
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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 in patients with advanced solid tumors

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2022-02-08
• Status Verified: 2022-10
• Primary Completion: 2023-07-27
• Study Completion: 2023-08-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one evaluable or measurable lesion per RECIST 1.1
3. Male or female subject at least 18 years old and no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
6. Be able to provide archived or fresh tumor tissues-

Exclusion Criteria

1. Previous exposure to any anti-CD73 monoclonal antibody
2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
3. Unstable central nervous system netastases
4. Known active autoimmune disease or inflammatory disease
5. Known active infectious disease
6. Other uncontrolled systematic disease that may increase the risk of participating the study-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI325 and sintilimab combination does-escalation	IBI325 + sintilimab	-
IBI325 monotherapy does-escalation	IBI325	-

Primary Outcome Measures

Name	Time	Method
Number of patients with DLT	28 days post first dose	Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose
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

Secondary Outcome Measures

Name	Time	Method
The area under the curve (AUC)	Up to 90 days post last dose
Maximum concentration (Cmax)	Up to 90 days post last dose
Time at which maximum concentration (Tmax)	Up to 90 days post last dose
Number of patients with response	Every 6 weeks until progressive disease or up to 24 months after treatment	Number of patients with response per RECIST 1.1
The half-life (t1/2)	Up to 90 days post last dose
Positive rate of ADA and Nab	Up to 90 days post last dose

Trial Locations

Locations (1)

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