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

September 14, 2021 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

312

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
Drug: SYHX1903
SYHX1903 tablets, orally, qd
Experimental: Arm 2
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
Drug: SYHX1903
SYHX1903 tablets, orally, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
28 days
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 29, 2021

Primary Completion (Anticipated)

June 20, 2026

Study Completion (Anticipated)

September 20, 2026

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYHX1903-CSP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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