Clinical trial NCT04443751: A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Official title: A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AML
MDS
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
timeFrame: 2 years
measure: Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
timeFrame: 2 years
measure: Immunogenicity as assessed by the presence of anti-drug antibodies
timeFrame: 2 years
measure: Pharmacodynamic profile as assessed by receptor occupancy
timeFrame: 2 years
measure: Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006
timeFrame: 2 years
measure: Best of Response（BOR）for SHR-1702 in AML or high risk MDS
timeFrame: 2 years
measure: Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS
timeFrame: 2 years
measure: Overall Survival（OS) for SHR-1702 in AML or high risk MDS
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Blood disease hospital of Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References: