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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Trial Status: active
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
Inclusion 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
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)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07029399.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Charlestown
Massachusetts General Hospital
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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.
