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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥18 years in age, male or female.
- Relapsed/refractory AML patients.
- ECOG performance status score is 0 to 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow and good organ function.
- Ability to understand the purpose and risks of the study and the willingness to sign awritten informed consent document.
Exclusion
Exclusion Criteria:
- 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.
- Receiving any other investigational agents within 4 weeks prior to starting studytreatment.
- Having major surgery within 4 weeks prior to starting study treatment, or intended toundergo surgery during the trail.
- AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blastcrisis of chronic myelogenous leukemia; 3) central nervous system leukemia.
- 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.
- Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior tostarting study treatment.
- Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatmentand/or planning to receive (attenuated) live vaccines during the trial.
- 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.
- Patients who have received previous allogeneic hematopoietic stem celltransplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.
- Unable to swallow oral tablets, or other conditions seriously affectinggastrointestinal absorption judged by the investigator.
- Patients with uncontrolled infections unsuitable for the trail judged by theinvestigator.
- Known infection with hepatitis B, hepatitis C, HIV or Syphilis.
- Known alcohol or drug dependence.
- Patients with mental disorders or poor compliance.
- Patients with a previous history of severe allergy to any drug or food.
- 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.
- 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
ChinaActive - Recruiting

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