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

A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors

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

Study Overview

• Status: Completed
• Conditions: Advanced Malignancies
• Intervention / Treatment: Biological: IBI322

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBI322; Single arm	Biological: IBI322; Recombinant anti-human CD47/PD-L1 bispecific antibody injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive rate of ADA and Nab	Up to 90 days post last dose
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
PK parameters: The half-life (t1/2)	Up to 90 days post last dose
Positive rate of Circulating Immune Complex	Up to last dose

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oncology
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI322A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No