A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors
NiKang Therapeutics, Inc.
205 participants
Mar 25, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097
Eligibility
Inclusion Criteria11
- Able to provide written informed consent
- Advanced unresectable or metastatic solid tumor
- Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
- Measurable or evaluable disease (Part 1 \& 2 only)
- Eighteen years of age or older
- ECOG status of 0 or 1
- Adequate organ function
- Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
- Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
- Able to swallow oral meds
- Willing to provide tumor tissue
Exclusion Criteria10
- Advanced solid tumor that is a candidate for curative treatment
- History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
- Not recovered from the effects of prior anticancer therapy
- Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
- Known active CNS metastases and/or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
- History of uveitis, retinopathy, or other clinically significant retinal disease
- Major surgery within 30 days of administration of first dose
- Active uncontrolled infectious disease
- Significant liver disease (Child Pugh class B or C)
Interventions
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07029399