Phase 1Recruiting
A Study With NKT3964 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 CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors
- Sponsor
- NiKang Therapeutics, Inc. (Industry)
- Enrolment
- 238 planned
- Conditions
- Solid Tumor; Advanced Solid Tumor; Solid Tumor, Adult; Metastatic Tumor; Ovarian Cancer; Ovarian Neoplasms; Ovarian Carcinoma; Metastatic Ovarian Carcinoma; Endometrial Neoplasms; Endometrial Diseases; Metastatic Endometrial Cancer; Triple Negative Breast Cancer
- Interventions
- NKT3964; Paclitaxel; Doxorubicin
- Ages
- adults, older adults
- Registry
- NCT06586957
From the registry
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.
Primary outcomes
- Number of Participants with Dose Limiting Toxicity (DLT) events
- Objective Response Rate (ORR)