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Not yet recruiting NCT05055791

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

Phase I / Phase II Interventional Acute Myeloid Leukemia Lymphoma Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SYHX1903.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Lymphoma, Multiple Myeloma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SYHX1903
    SYHX1903 tablets, orally, qd

Primary outcome measures

  • Dose limiting toxicities [Time frame: 28 days]
  • Incidence of adverse events [Time frame: 1 year]
  • Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR) [Time frame: 1 year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05055791 · SYHX1903-CSP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗