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

NCT ID: NCT05055791

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2026-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia Lymphoma Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

SYHX1903

Intervention Type DRUG

SYHX1903 tablets, orally, qd

Arm 2

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

Group Type EXPERIMENTAL

SYHX1903

Intervention Type DRUG

SYHX1903 tablets, orally, qd

Interventions

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SYHX1903

SYHX1903 tablets, orally, qd

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SYHX1903-CSP-001

Identifier Type: -

Identifier Source: org_study_id

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