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Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04328831•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cancer hospital Chinese academy of Medical sciences

Beijing, China

Key Dates

Start Date

July 31, 2020

Primary Completion Date

August 28, 2023

Completion Date

August 28, 2023

Last Updated

October 10, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Malignancies

Interventions

IBI322

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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