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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, 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
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)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07029399.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
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
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
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
Pennsylvania
Pittsburgh
UPMC Hillman Cancer Center
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
Houston
UT MD 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: 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.
