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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country31 target enrollmentSeptember 10, 2020

ConditionsAML MDS

InterventionsSHR-1702

DrugsSHR-1702

Overview

Phase: Phase 1
Intervention: SHR-1702
Conditions: AML
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 31
Locations: 1
Primary Endpoint: The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 10, 2020

End Date

February 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

SHR-1702 monotherapy

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

Intervention: SHR-1702

Outcomes

Primary Outcomes

The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.

Time Frame: 6 months

Secondary Outcomes

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)
Immunogenicity as assessed by the presence of anti-drug antibodies(2 years)
Pharmacodynamic profile as assessed by receptor occupancy(2 years)
Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006(2 years)
Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS(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)