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

NCT ID: NCT06049667

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2026-08-31

Brief 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.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NTQ2494

For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).

Group Type: EXPERIMENTAL

NTQ2494 tablet

Intervention Type: DRUG

Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria.

For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle).

Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).

Interventions

NTQ2494 tablet

Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria.

For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle).

Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).

Intervention Type: DRUG

Eligibility Criteria

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.

11. Patients with uncontrolled infections unsuitable for the trail judged by the investigator.

12. Known infection with hepatitis B, hepatitis C, HIV or Syphilis.

13. Known alcohol or drug dependence.

14. Patients with mental disorders or poor compliance.

15. Patients with a previous history of severe allergy to any drug or food.

16. Lactating or pregnant female, and females or males (or partners) who plan to pregnant and do not agree to use adequate contraception for the duration of the trail and up to 3 months after completion of the last study treatment.

17. Other reasons judged by the investigator that the patients unsuitable for the trail.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Chia-tai Tianqing Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu meng Zhou

Role: CONTACT

yumeng_zhou@163.com

86-025-85109999

Facility Contacts

jianxiang wang

Role: primary

Other Identifiers

NTQ2494-23101

Identifier Type: -

Identifier Source: org_study_id