Actively Recruiting
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 AdvancedMetastatic Solid Tumors
Led by NiKang Therapeutics, Inc. · Updated on 2026-04-21
150
Participants Needed
19
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of a novel oral drug called NKT3964 in adults with advanced or metastatic solid tumors. The study aims to find the recommended dose for further testing and to observe how the drug affects various types of advanced cancers, including ovarian, endometrial, gastric, lung, and breast cancers, particularly those with specific genetic markers like CCNE1 amplification. The study has two main phases Dose Escalation and Dose Expansion. In the Dose Escalation phase, participants receive increasing doses of NKT3964 to assess safety, side effects, and appropriate dosing. The Dose Expansion phase uses the recommended dose from the first phase to further evaluate the drugs anti-tumor activity in specific tumor types. Both phases involve oral administration of the study drug, with detailed criteria for patient eligibility based on cancer type, prior treatments, and genetic markers. Participants will undergo regular assessments including physical exams, laboratory tests, imaging scans, and tumor biopsies before and during treatment. Researchers will monitor drug levels in the blood, treatment side effects, and tumor responses using standard criteria over periods ranging from one month to two years. The study also tracks progression-free survival, overall survival, and other measures to understand the drugs impact and safety profile. Participation involves ongoing monitoring and follow-up visits throughout the study duration.
CONDITIONS
Brief Title
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed advanced and unresectable or metastatic solid tumor with documented progression on last standard treatment
- For dose escalation: refractory or intolerant to existing therapies providing clinical benefit
- Specific tumor types including ovarian, endometrial (endometrioid subtype with CCNE1 amplification), gastric, gastroesophageal junction or esophageal adenocarcinoma with CCNE1 amplification, small cell lung cancer, triple-negative breast cancer, HR+ HER2- breast cancer progressed after CDK4/6 inhibitor treatment and not suitable for endocrine therapy, and other solid tumors with CCNE1 amplification
- ECOG performance status 0-1
- Adequate organ function
- Female participants must be surgically sterile, post-menopausal, or use effective contraception if of child-bearing potential
- Ability to swallow oral medications
- Consent to provide archived tumor tissue and paired tumor biopsies at pretreatment and on-treatment
You will not qualify if you...
- Locally advanced solid tumor suitable for curative surgery, radiotherapy, or chemotherapy
- History of another malignancy with exceptions
- History of lymphohistiocytic or lymphoid hyperplasia or hemophagocytic lymphohistiocytosis
- Failure to recover to baseline or Grade 1 severity from prior anticancer treatment effects
- Significant cardiovascular event within 6 months prior to treatment
- Known active central nervous system metastases or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
- History of uveitis, retinopathy, or other significant retinal disease
- Active or chronic corneal disorders or significant ocular disease
- Active wound healing from major surgery within 1 month or minor surgery within 10 days before first dose
- Known HIV, active hepatitis B or C infection
- Prior treatment with selective or nonselective CDK2 inhibitors or degraders
- Child-Pugh class B or C cirrhosis or other significant liver disorders
- Recent palliative radiation therapy within 14 days or other radiation within 4 weeks prior to first treatment day
Research Team
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