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- NKT3964-101 / A Phase 1, First-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 Degrader NKT3964 in adults with advanced/metastatic solid tumors
Clinical Trial
NKT3964-101 / A Phase 1, First-in-human, open-label study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of the novel oral CDK2 Degrader NKT3964 in adults with advanced/metastatic solid tumors
This is a Phase 1, first?in?human, study testing a new oral cancer drug, NKT3964, to evaluate safety, tolerability, and early signs of tumor control in adults with advanced/ metastatic solid cancers when standard treatments are no longer effective.
- Female Reproductive System
- Advanced Or Metastatic Cancer
- Cancer Therapy
- Gynecologic Malignancies
- NKT3964
- Phase 1 Cancer Study
- Solid Tumors
Eligibility Criteria
- Inclusion Participants must be equal to or greater than 18 years of age at the time of consent. Participants must have an advanced or metastatic solid tumor that cannot be cured with surgery or radiation and has progressed after standard treatments, or for which no standard treatment is expected to provide further benefit. Participants must be mostly able to care for themselves and carry out daily activities (ECOG 0 or 1), and must have kidney (CrCL ? 60 mL/min) and liver function within safe ranges based on routine blood tests. Exclusion People with specific eye diseases or ongoing eye problems (such as retinal disease, inflammation inside the eye, or serious corneal conditions) cannot participate because the study drug requires close eye monitoring. People who need to take certain stomach?acid?reducing medications (like proton pump inhibitors) or who have digestive conditions or surgeries that could affect absorption of an oral drug.
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