Clinical trial · Interventional
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
NCT06049667CI-TRIAL-00069849unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NTQ2494 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NTQ2494
- description
- For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).
- interventionNames
- Drug: NTQ2494 tablet
Primary outcomes (1)
- measure
- Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)
- timeFrame
- 30 days
- description
- MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.
Secondary outcomes (24)
- measure
- Cmax of single dose
- timeFrame
- At the end of Cycle 1 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.