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

NCT ID: NCT04443751

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2023-02-28

Brief Summary

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

Conditions

AML; MDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1702 monotherapy

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

Group Type: EXPERIMENTAL

SHR-1702

Intervention Type: DRUG

SHR-1702 monotherapy, administered IV

Interventions

SHR-1702

SHR-1702 monotherapy, administered IV

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Blood disease hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

SHR-1702-I-102

Identifier Type: -

Identifier Source: org_study_id