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

Description

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

Conditions

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)CCNE1 Amplified Advanced Solid TumorsHR+ HER2- Breast CancerOvarian CancerEndometrial CancerUterine Carcinosarcoma
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Related Conditions:

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

Study Overview

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Study Details

Study overview

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

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

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

Condition
HR+ Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, United States, 49546

San Antonio

South Texas Accelerated Research Therapeutics (START) San Antonio, San Antonio, Texas, United States, 78229

West Valley City

South Texas Accelerated Research Therapeutics (START) Mountain Region, West Valley City, Utah, United States, 84119

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Able to provide written informed consent
  • * Advanced unresectable or metastatic solid tumor
  • * Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
  • * Measurable or evaluable disease (Part 1 \& 2 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NiKang Therapeutics, Inc.,

Study Record Dates

2027-12-31