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A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Preliminary Efficacy of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies

NCT06049667•Nanjing Chia-tai Tianqing Pharmaceutical

View on ClinicalTrials.gov

Summary

NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor. The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years in age, male or female.
•2. Relapsed/refractory AML patients.
•3. ECOG performance status score is 0 to 2.
•4. Life expectancy of at least 3 months.
•5. Adequate bone marrow and good organ function.
•6. Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document.

Exclusion Criteria

•1. Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.
•2. Receiving any other investigational agents within 4 weeks prior to starting study treatment.
•3. Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.
•4. AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
•5. Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and/or other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for \> 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.
•6. Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior to starting study treatment.
•7. Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatment and/or planning to receive (attenuated) live vaccines during the trial.
•8. With unresolved clinically significant non-hematological toxicities from prior AML therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery), defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events that are tolerable as judged by the investigator.
•9. Patients who have received previous allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.
•10. Unable to swallow oral tablets, or other conditions seriously affecting gastrointestinal absorption judged by the investigator.
+7 more criteria

Locations (1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

August 7, 2023

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

September 22, 2023

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Interventions

NTQ2494 tablet

DRUG

Contacts

Yu meng Zhou

CONTACT

86-025-85109999 yumeng_zhou@163.com

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT05143996

Relapsed/Refractory Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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