AML, MDS
Conditions
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
Interventions
DRUGSHR-1702
SHR-1702 monotherapy, administered IV
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Anti SHR-1702 antibodies will be tested frequently |
| Pharmacodynamic profile as assessed by receptor occupancy | 2 years | SHR-1702 receptor occupation |
| 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 | — |
| 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 | — |
| Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006 | 2 years | — |
Countries
China
Outcome results
None listed