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

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443751
• Other study ID #: SHR-1702-I-102
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid, Acute
• MDS
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• SHR-1702
SHR-1702 monotherapy, administered IV

Locations

Country	Name	City	State
China	Blood disease hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.		6 months
Secondary	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
Secondary	Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS		2 years
Secondary	Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS		2 years
Secondary	Immunogenicity as assessed by the presence of anti-drug antibodies	Anti SHR-1702 antibodies will be tested frequently	2 years
Secondary	Pharmacodynamic profile as assessed by receptor occupancy	SHR-1702 receptor occupation	2 years
Secondary	Objective response rate(ORR)for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006		2 years
Secondary	Best of Response(BOR)for SHR-1702 in AML or high risk MDS		2 years
Secondary	Progression-Free Survival(PFS) for SHR-1702 in AML or high risk MDS		2 years
Secondary	Overall Survival(OS) for SHR-1702 in AML or high risk MDS		2 years