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

NCT04443751 | Completed Phase 1

• 1 other identifier: SHR-1702-I-102
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (9)

• 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

  2 years

• Pharmacodynamic profile as assessed by receptor occupancy

  2 years

Study Arms (1)

SHR-1702 monotherapy

EXPERIMENTAL

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

Drug: SHR-1702

Interventions

SHR-1702 DRUG

SHR-1702 monotherapy, administered IV

SHR-1702 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Blood disease hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300041, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: September 10, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)