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

NCT05055791 | Not Yet Recruiting Phase 1

• 1 other identifier: SYHX1903-CSP-001
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Myeloid Leukemia; Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: SYHX1903

Arm 2

EXPERIMENTAL

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

Drug: SYHX1903

Interventions

SYHX1903 DRUG

SYHX1903 tablets, orally, qd

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: September 24, 2021
• Study Start: December 29, 2021
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share