A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Efficacy of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies
Overview
- Phase
- Phase 1
- Intervention
- SYHX1903
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 312
- Primary Endpoint
- Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR)
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of relapsed/refractory hematologic malignancies confirmed by the World Health Organization (WHO) criteria.
- •Eastern Cooperative Oncology Group (ECOG) score ≤
- •Life expectancy ≥ 3 months.
Exclusion Criteria
- •Pregnant and lactating females.
- •Proven hematologic malignancies of the central nervous system.
- •Diagnosed acute promyelocytic leukemia (predominantly granulocytic promyelocytes in bone marrow, which are ≥ 30% in NEC).
- •History of other malignant tumors within 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ.
Arms & Interventions
Arm 1
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
Intervention: SYHX1903
Arm 2
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
Intervention: SYHX1903
Outcomes
Primary Outcomes
Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR)
Time Frame: 1 year
To assess proportion of patients with anti tumor response to SYHX1903. response assessment by Cheson (2014) criteria and myeloma (Palumbo 2014) Response will be evaluated every 4-12 weeks (based on disease type) until progression
Dose limiting toxicities
Time Frame: 28 days
DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG).
Incidence of adverse events
Time Frame: 1 year
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters