Testing NTQ2494 tablets in patients with advanced blood cancers

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

This study tests if NTQ2494 tablets can help adults with advanced blood cancers, like relapsed or refractory acute myeloid leukemia, feel better and manage their disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06049667 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of NTQ2494 tablets, an AXL kinase inhibitor, in patients suffering from advanced hematological malignancies, specifically relapsed or refractory acute myeloid leukemia (AML). The study aims to enroll adult patients who meet specific eligibility criteria, including performance status and organ function. Participants will receive NTQ2494 and be monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with relapsed or refractory acute myeloid leukemia.

Not a fit: Patients with acute promyelocytic leukemia or those currently receiving other anticancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced AML who have limited treatment choices.

How similar studies have performed: While this specific approach is novel, similar studies targeting AXL kinase inhibitors have shown promise in other hematological malignancies.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yu meng Zhou

Conditions Relapsed/Refractory Acute Myeloid Leukemia