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NCT07029399PHASE1Recruiting

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

NiKang Therapeutics, Inc.

Start Date

3/25/2025

Completion Date

12/31/2027

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, for both monotherapy and in combination with ET * What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

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: Monotherapy 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: Monotherapy 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 Part 4: Combination Dose Escalation with ET in selected HR+/HER2- breast cancer will be enrolled based on a projected 2 dose levels Part 5: Combination Dose Expansion with ET in HR+/HER2- breast cancer in one or more various cohorts In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Able to provide written informed consent * Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only) * Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only) * Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only) * Measurable or evaluable disease (Part 1, 2, \& 4 only). * Measurable disease (Part 3 \& 5 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 Criteria: * 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) * Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)

Interventions

DRUG

NKT5097 CDK2/CDK4 dual degrader

DRUG

Fulvestrant

DRUG

Letrozole

Interested in This Trial?

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Conditions

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)CCNE1 Amplified Advanced Solid TumorsHR+ HER2- Breast Cancer

Locations

City of Hope

Duarte, California 91010

United States

UC San Diego Moores Cancer Center

La Jolla, California 92037

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

United States

Yale Cancer Center

New Haven, Connecticut 06520

United States

SCRI Florida Cancer Specialists - Sarasota

Sarasota, Florida 34232

United States

University of Iowa

Iowa City, Iowa 52242

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02115

United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan 49546

United States

Washington University

St Louis, Missouri 63110

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics (START) San Antonio

San Antonio, Texas 78229

United States

South Texas Accelerated Research Therapeutics (START) Mountain Region

West Valley City, Utah 84119

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

West Virginia University

Morgantown, West Virginia 26506

United States