A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Study Overview
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Brief Summary
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This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS

Official Title
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A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Conditions
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AML, MDS

Intervention / Treatment
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* Drug: SHR-1702


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female. ≥18 years of age. Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy. Intermediate, High and very high risk MDS according to the revised International Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as azacitidine and decitabine (Scoring≥3.5). Life expectancy≥12 months. With Adequate hematologic and organ function Signed inform consent form Exclusion Criteria: With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. With significant cardiovascular disease. With a history of autoimmune disease. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease. Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C. Active or untreated central nervous system (CNS) metastases. Active infection within 2 weeks. Know to be allergic to the ingredients of SHR-1702 injection. Prior allogeneic bone marrow transplantation or solid organ transplant With a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

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: SHR-1702 monotherapy<br>SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion. | Drug: SHR-1702<br>* SHR-1702 monotherapy, administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients |  | 2 years | 
| Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS |  | 2 years | 
| Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS |  | 2 years | 
| Immunogenicity as assessed by the presence of anti-drug antibodies | Anti SHR-1702 antibodies will be tested frequently | 2 years | 
| Pharmacodynamic profile as assessed by receptor occupancy | SHR-1702 receptor occupation | 2 years | 
| Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006 |  | 2 years | 
| Best of Response（BOR）for SHR-1702 in AML or high risk MDS |  | 2 years | 
| Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS |  | 2 years | 
| Overall Survival（OS) for SHR-1702 in AML or high risk MDS |  | 2 years |