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

NCT ID: NCT04328831

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2023-08-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI322

Single arm

Group Type OTHER

IBI322

Intervention Type BIOLOGICAL

Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Interventions

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IBI322

Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer hospital Chinese academy of Medical sciences

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CIBI322A101

Identifier Type: -

Identifier Source: org_study_id

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