Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
Megadott ok: Sponsor decision
Key facts
- Where
- Birmingham, Boston, Chapel Hill, Columbus, Houston, Milwaukee, Minneapolis, Nashville, New York, Portland, San Francisco és The Bronx, Egyesült ÁllamokSee the 13 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
- Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, Egyesült ÁllamokNo longer taking part
- James Cancer Hospital and Solove Research InstituteColumbus, Egyesült ÁllamokNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- The Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
- University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- TriStar Bone Marrow TransplantNashville, Egyesült ÁllamokNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- NYU Langone HealthNew York, Egyesült ÁllamokNo longer taking part
- Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- University of California San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
- Albert Einstein College of Medicine - Montefiore Medical CenterThe Bronx, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
- Trial code
- NCT05682170
- Record updated
- 2024. szeptember 19.
- Original description
A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).Read full original descriptionShow less
A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia
A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).
Inclusion: Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort A; ECOG performance status score ≤2; Projected life expectancy of at least 12 weeks; Estimated glomerular filtration rate ≥60 mL/min; Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs; Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.
Exclusion: Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower; Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers; Significant cardiovascular disease; Active hepatitis B or hepatitis C infection; Peripheral blast count of >25 × 109/L (cytoreduction permitted); Corrected QT interval (QTc) of >480 msec; Known active CNS involvement; Diagnosis of acute promyelocytic leukemia.