IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.

Phase 1

Completed

• Conditions: Advanced Solid Tumor

• Registration Number: NCT04912466
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Study Start: 2021-07-21
• Primary Completion: 2022-12-03
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
2. Per RECIST1, at least one evaluable or measurable 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. Direct coombs test was positive or have history of hemolytic anemia.
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of treatment related AEs	up to 90 days post last dose
Number of DLT	21 Days
Number of patients with response	Last patient enrolled+24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shandong Province Cancer Hospital; 🇨🇳 Jinan, Shandong, China