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

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country61 target enrollmentJuly 21, 2021

ConditionsAdvanced Solid Tumor

DrugsBiological: IBI322

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumor
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 61
Locations: 1
Primary Endpoint: Number of treatment related AEs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.

Registry

clinicaltrials.gov

Start Date

July 21, 2021

End Date

August 25, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
•Per RECIST1, at least one evaluable or measurable lesion.
•Male or female subject above 18 years old, no more than 75 years old.
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or
•Must have adequate organ function

Exclusion Criteria

•Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
•Direct coombs test was positive or have history of hemolytic anemia.
•Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
•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.)
•Subjects who have a history of blood transfusion within 2 weeks prior to the study.

Outcomes

Primary Outcomes

Number of treatment related AEs

Time Frame: up to 90 days post last dose

Number of DLT

Time Frame: 21 Days

Number of patients with response

Time Frame: Last patient enrolled+24 months

Secondary Outcomes

the distribution volumn (Vd)(Up to 90 days post last dose)
half-life period(t1/2)(Up to 90 days post last dose)
Peak Plasma concentration(Cmax)(Up to 90 days post last dose)
positive rate of ADA&NAB(from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.)
Reticulocyte count (RET)(Up to 90 days post last dose)
Biomarker evaluation(from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.)
Area under the plsma concentration versus time curve(AUC)(Up to 90 days post last dose)
Clearance rate(CL)(Up to 90 days post last dose)
Percentage of receptor occupancy(Up to 90 days post last dose)
Hemoglobin level(Up to 90 days post last dose)
platelet count (PLT)(Up to 90 days post last dose)