A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Sponsor: NiKang Therapeutics, Inc. • ClinicalTrials.gov ID: NCT06586957
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Check Eligibility →Description
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D). The goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.
Interventions
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NKT3964
(Drug)
Oral CDK2 Degrader
-
Paclitaxel
(Drug)
Paclitaxel will be administered on a 3 weeks on, 1 week off schedule at a dose of 80 mg/m2 IV. Subjects will receive a total of 6 cycles of paclitaxel.
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Doxorubicin
(Drug)
Doxorubicin will be administered every 3 weeks at a dose of 60 mg/m2 IV. Subjects will receive a total of 6 cycles of doxorubicin.
Eligibility criteria
Conditions
Locations
- University of Arkansas Medical School — Little Rock, Arkansas, United States
- University of California - Los Angeles — Los Angeles, California, United States
- UCSF — San Francisco, California, United States
- SCRI at HealthOne — Denver, Colorado, United States
- Florida Cancer Specialists & Research Institute — Lake Mary, Florida, United States
- AdventHealth Cancer Institute — Orlando, Florida, United States
- Emory Winship Cancer Institute — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- University of Kansas — Fairway, Kansas, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
- Sidney Kimmell Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States
- UPMC — Pittsburgh, Pennsylvania, United States
- Sarah Cannon Research Institute (SCRI) — Nashville, Tennessee, United States
- NEXT Oncology — Austin, Texas, United States
- UT Southwestern — Dallas, Texas, United States
- Intermountain Health — Salt Lake City, Utah, United States
- University of Virginia — Charlottesville, Virginia, United States
- NEXT Virginia — Fairfax, Virginia, United States
- Yonsei Cancer Center / Severance Hospital — Seoul, South Korea
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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