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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: AML; MDS

Treatments: Drug: SHR-1702

Study type: Interventional

Funder types: Industry

Identifiers

NCT04443751

SHR-1702-I-102

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female.
2. ≥18 years of age.
3. Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
4. 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).
5. Life expectancy≥12 months.
6. With Adequate hematologic and organ function
7. Signed inform consent form

Exclusion criteria

1. With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
2. With significant cardiovascular disease.
3. With a history of autoimmune disease.
4. 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.
5. Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
6. Active or untreated central nervous system (CNS) metastases.
7. Active infection within 2 weeks.
8. Know to be allergic to the ingredients of SHR-1702 injection.
9. Prior allogeneic bone marrow transplantation or solid organ transplant
10. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

SHR-1702 monotherapy

Experimental group

Description:

SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion.

Treatment:

Drug: SHR-1702