Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

Phase 1

Completed

• Conditions: Advanced Malignancies
• Interventions: Biological: IBI322

• Registration Number: NCT04328831
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Detailed Description

Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Study Start: 2020-07-31
• Primary Completion: 2023-08-28
• Study Completion: 2023-08-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one evaluable lesion.
3. Male or female subject above 18 years old, 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

Exclusion Criteria

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
4. Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI322	IBI322	Single arm

Primary Outcome Measures

Name	Time	Method
Number of DLT	28 days
Number of patients with response	Last patient enrolled+24 weeks
Number of treatment related AEs	90 days post last dose

Secondary Outcome Measures

Name	Time	Method
PK parameters: The area under the curve (AUC)	Up to 90 days post last dose
PK parameters: Maximum concentration (Cmax)	Up to 90 days post last dose
PK parameters: Time at which maximum concentration (Tmax)	Up to 90 days post last dose
Positive rate of Circulating Immune Complex	Up to last dose
PK parameters: 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)

Cancer hospital Chinese academy of Medical sciences; 🇨🇳 Beijing, China