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

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

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

Study Overview

• Status: Completed
• Conditions: AML; MDS
• Intervention / Treatment: Drug: SHR-1702

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300041
      • Blood disease hospital of Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1702 monotherapy; SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion.	Drug: SHR-1702; SHR-1702 monotherapy, administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Leukemia; Leukemia, Myeloid; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Preleukemia
• Other Study ID Numbers: SHR-1702-I-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No