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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: Biological: IBI322


Participation Criteria
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Eligibility Criteria
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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 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI322<br>Singal arm | Drug: Biological: IBI322<br>* Recombinant anti-human CD47/PD-L1 bispecific antibody injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of DLT |  | 21 Days | 
| Number of treatment related AEs |  | up to 90 days post last dose | 
| Number of patients with response |  | Last patient enrolled+24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Area under the plsma concentration versus time curve(AUC) |  | Up to 90 days post last dose | 
| Peak Plasma concentration(Cmax) |  | Up to 90 days post last dose | 
| Clearance rate(CL) |  | Up to 90 days post last dose | 
| the distribution volumn (Vd) |  | Up to 90 days post last dose | 
| half-life period(t1/2) |  | 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 | 
| Reticulocyte count (RET) |  | Up to 90 days post last dose | 
| platelet count (PLT) |  | Up to 90 days post last dose |