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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05055791
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Myeloid Leukemia, Lymphoma, Multiple Myeloma

Arms & Interventions

Arms

Experimental: Arm 1

Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.

Experimental: Arm 2

Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.

Interventions

Drug: - SYHX1903

SYHX1903 tablets, orally, qd

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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