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NCT05055791 Clinical Trial

A Study to Evaluate the Safety and Tolerance of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies

Multiple Myeloma Clinical Trial

Official title:
A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Efficacy of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05055791
Other study ID # SYHX1903-CSP-001
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 29, 2021
Est. completion date September 20, 2026

Study information
Verified date August 2021
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 312
Est. completion date September 20, 2026
Est. primary completion date June 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosis of relapsed/refractory hematologic malignancies confirmed by the World Health Organization (WHO) criteria. - Eastern Cooperative Oncology Group (ECOG) score = 1. - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SYHX1903
SYHX1903 tablets, orally, qd

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Dose limiting toxicities 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). 28 days
Primary Incidence of adverse events Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters 1 year
Primary Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR) 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 1 year
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