OncoMatch

OncoMatch/Clinical Trials/NCT07029399

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Is NCT07029399 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NKT5097 CDK2/CDK4 dual degrader for hr+ breast cancer.

Phase 1RecruitingNiKang Therapeutics, Inc.NCT07029399Data as of May 2026

Treatment: NKT5097 CDK2/CDK4 dual degraderThe 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

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Tumor Agnostic

Ovarian Cancer

Endometrial Cancer

Biomarker criteria

Required: CCNE1 amplification

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function; Significant liver disease (Child Pugh class B or C) [excluded]

Adequate organ function; Significant liver disease (Child Pugh class B or C) [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UC San Diego Moores Cancer Center · La Jolla, California
  • Sarah Cannon Research Institute at HealthONE · Denver, Colorado
  • Yale Cancer Center · New Haven, Connecticut
  • SCRI Florida Cancer Specialists - Sarasota · Sarasota, Florida
  • Dana-Farber Cancer Institute · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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