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

Last updated: September 17, 2023
Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Neoplasms

Treatment

NTQ2494 tablet

Clinical Study ID

NCT06049667
NTQ2494-23101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 awritten informed consent document.

Exclusion

Exclusion Criteria:

  1. Receiving anticancer therapy including immunotherapy, targeted therapy, endocrinetherapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever islonger) prior to starting study treatment.
  2. Receiving any other investigational agents within 4 weeks prior to starting studytreatment.
  3. Having major surgery within 4 weeks prior to starting study treatment, or intended toundergo surgery during the trail.
  4. AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blastcrisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
  5. Prior or current other malignancy (except cured noninvasive basal cell or squamouscell skin cancer and/or other cured carcinoma in situ; except for other malignanciesthat have achieved clinical cure for > 5 years and have not recurred within 5years).History of severe cardiovascular or cerebrovascular disease.
  6. Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior tostarting study treatment.
  7. Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatmentand/or planning to receive (attenuated) live vaccines during the trial.
  8. With unresolved clinically significant non-hematological toxicities from prior AMLtherapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery),defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events thatare tolerable as judged by the investigator.
  9. Patients who have received previous allogeneic hematopoietic stem celltransplantation; 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 affectinggastrointestinal absorption judged by the investigator.
  11. Patients with uncontrolled infections unsuitable for the trail judged by theinvestigator.
  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 pregnantand 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.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: NTQ2494 tablet
Phase: 1
Study Start date:
August 07, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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