A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

Study Overview
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Brief Summary
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This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Detailed Description
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Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.

Official Title
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A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

Conditions
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Myeloid Tumor

Intervention / Treatment
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* Drug: IBI322


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia) Male or female subject above 18 years old Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0   2. Must have adequate organ function Exclusion Criteria: Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN Transformation or treatment related AML/MDS. PV/MF/AML/MDS evolved from Essential thrombocythemia Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year Central nervous system leukemia infiltration Previous history of chronic hemolytic anemia or screening Coombe test positive Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose Uncontrolled concurrent diseases Subjects who are allergic to the ingredients of the study drug Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment

Ages Eligible for Study
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Minimum Age: 18 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> | Drug: IBI322<br>* Recombinant anti-human CD47/PD-L1 bispecific antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment related AEs | safety and tolerability | Up to 90 days post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with response | preliminary efficacy | Last patient enrolled+24 weeks |