NCT07029399

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: NiKang Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of NKT5097, a novel dual protein degrader of CDK2 and CDK4, is split into 3 Parts: Part 1: Dose Escalation in selected advanced/metastatic non-CNS primary solid tumors will be enrolled based on a projected total of 5 dose levels Part 2: Food Effect Analysis: Subjects with solid tumors (as noted in Part 1) will be enrolled (by backfilling selected dose cohorts) to evaluate the effect of dosing with food on NKT5097. Part 3: Tumor-specific Expansion: Subjects may be enrolled (by backfilling selected dose cohorts) into each selected tumor-specific cohort. One or more of these cohorts may be opened at the discretion of the Sponsor in consultation with the DEC In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.

Conditions

• HR+ Breast Cancer
• Triple Negative Breast Cancer (TNBC)
• CCNE1 Amplified Advanced Solid Tumors
• HR+ HER2- Breast Cancer
• Ovarian Cancer
• Endometrial Cancer
• Uterine Carcinosarcoma

Interventions

Type	Name	Description
DRUG	NKT5097 CDK2/CDK4 dual degrader	NKT5097 will be distributed in tablet form and dosed daily or twice a day

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2025-06-19
• Last updated: 2026-03-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study