A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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)
Study sites (18)
CA
- City of Hope · Duarte, CA 91010Jenny Sanchez · Study contact · 949-671-4920 · jesanchez@coh.orgHope Rugo, MD · Principal investigatorMore trials in Duarte
- UC San Diego Moores Cancer Center · La Jolla, CA 92037Cristal Martinez · Study contact · 858-822-5223 · cmm015@health.ucsd.eduRebecca Shatsky, MD · Principal investigatorMore trials in La Jolla
CO
- Sarah Cannon Research Institute at HealthONE · Denver, CO 80218SCRI Contact Email · Study contact · 720-754-2610 · CANN.DDUDenverGeneral@SarahCannon.comGerald Falchook, MD · Principal investigatorMore trials in Denver
CT
- Yale Cancer Center · New Haven, CT 06520Priscilla Steve · Study contact · 203-785-4069 · Priscilla.Steve@yale.eduAdriana Kahn, MD · Principal investigatorMore trials in New Haven
FL
- SCRI Florida Cancer Specialists - Sarasota · Sarasota, FL 34232Carly Taylor · Study contact · 941-377-9993 · ctaylor@flcancer.comJudy Wang, MD · Principal investigatorMore trials in Sarasota
IA
- University of Iowa · Iowa City, IA 52242Clinical Trial Inquiry Line · Study contact · 319-353-8155 · kerri-fitch@uiowa.eduMark Burkard, MD · Principal investigatorMore trials in Iowa City
MA
- Dana-Farber Cancer Institute · Boston, MA 02115Dana Faber Institutional clinical.gov contact · Study contact · 877-338-7425Antonio Giordano, MD · Principal investigatorMore trials in Boston
MI
- South Texas Accelerated Research Therapeutics (START) Midwest · Grand Rapids, MI 49546Ashley Spagnuolo · Study contact · 616.954.5552 · ashley.spagnuolo@startresearch.comManish Sharma · Principal investigatorMore trials in Grand Rapids
MO
- Washington University · St Louis, MO 63110Katlyn Kraft · Study contact · 314-747-5440 · Katlyn.Kraft@wustl.eduFaisal Fa'ak, MD · Principal investigatorMore trials in St Louis
NV
- Comprehensive Cancer Centers of Nevada · Las Vegas, NV 89169Ann Lovelace · Study contact · 702-609-9460 · Ann.lovelace@usoncology.comFadi Braiteh, MD · Principal investigatorMore trials in Las Vegas
OH
- Cleveland Clinic · Cleveland, OH 44195Cancer Answer · Study contact · 216-444-7923 · TaussigResearch@ccf.orgAzka Ali, MD · Principal investigatorMore trials in Cleveland
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232Julie Urban · Study contact · 412-623-7396 · IDDCReferrals@upmc.eduMarija Balic, MD, PhD, MBA · Principal investigatorMore trials in Pittsburgh
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390Jennifer Knight · Study contact · 214-645-7097 · Jennifer.Knight@UTSouthwestern.eduNisha Unni, MD · Principal investigatorMore trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030Ileana Gutierrez · Study contact · 832-829-2161 · ilgutierrez@mdanderson.orgTimothy Yap, MD · Principal investigatorMore trials in Houston
- South Texas Accelerated Research Therapeutics (START) San Antonio · San Antonio, TX 78229Isabel Jimenez · Study contact · 210-593-5265 · isabel.jimenez@startresearch.comAmita Patnaik · Principal investigatorMore trials in San Antonio
UT
- South Texas Accelerated Research Therapeutics (START) Mountain Region · West Valley City, UT 84119HOPE Team · Study contact · 801-907-4750 · hopeteam@startresearch.comWilliam McKean · Principal investigatorMore trials in West Valley City
VA
- NEXT Virginia · Fairfax, VA 22031Blake Patterson · Study contact · 703-783-4505 · bpatterson@nextoncology.comAlexander Spira · Principal investigatorMore trials in Fairfax
WV
- West Virginia University · Morgantown, WV 26506Emily Hawkins · Study contact · 304-293-7375 · emily.hawkins@hsc.wvu.eduBei Jiang, MD, PhD · Principal investigatorMore trials in Morgantown