A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Hematologic Malignancy

Treatments: Biological: IBI322

Study type: Interventional

Funder types: Industry

Identifiers

NCT04795128

CIBI322A103

Details and patient eligibility

About

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

Full description

This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment
2. At least one evaluable lesion
3. Male or female 18 to 75 years old
4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2
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 chimeric antigen receptor T cell immunotherapy (CAR-T)
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start
5. A history of blood transfusion within 2 weeks prior to study start

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

IBI322

Other group

Description:

Single arm

Treatment:

Biological: IBI322