> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-with-nkt5097-for-adults-with-advanced-metastatic-5932c019-1225-49e6-bff6-6eb866c4bca0 > Record changed: 2026-10-13 # A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors NCT07029399 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Participants 361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Lead sponsor NiKang Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Start date 2025-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) Number of sites 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Short title** A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **First posted** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Primary completion date** 2027-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Start date** 2025-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Size and sites **Participants** 361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Planned participants** 361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Number of sites** 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Lead sponsor** NiKang Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Identifiers **Registry ID** NCT07029399 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **ClinicalTrials.gov ID** NCT07029399 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Outcomes ### Primary outcomes 1. Incidence of dose-limiting toxicities as Assessed by CTCAE Timeframe: From enrollment through end of safety monitoring period of 28 days from first dose ### Secondary outcomes 1. Incidence of adverse events (AEs) as defined by CTCAE Version 5 Timeframe: From enrollment through end of treatment up to 2 years 2. Maximum concentration Cmax after a single dose and multiple doses Timeframe: Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days) 3. Area under the concentration-time curve (AUC last) after a single dose and multiple doses from first dose through the last timepoint with quantifiable concentration (Tlast) Timeframe: Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days) 4. Maximum concentration (Cmax) when dosed with and without food Timeframe: Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days) 5. Area under the concentration-time curve (AUC last) when dosed with and without food from dosing through the last timepoint with quantifiable concentration (Tlast) Timeframe: Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days) 6. Time to maximum plasma concentration (Tmax) after a single dose and multiple doses Timeframe: Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days) 7. Investigator-assessed ORR by RECIST v1.1 Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months 8. Investigator-assessed PFS by RECIST v1.1 Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months 9. Duration of Response (DOR) Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Sites - City of HopeDuarte, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - SCRI Florida Cancer Specialists - SarasotaSarasota, United StatesRecruiting - University of IowaIowa City, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting - Washington UniversitySt Louis, United StatesRecruiting - Comprehensive Cancer Centers of NevadaLas Vegas, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting - University of Texas Southwestern Medical CenterDallas, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - South Texas Accelerated Research Therapeutics (START) San AntonioSan Antonio, United StatesRecruiting - South Texas Accelerated Research Therapeutics (START) Mountain RegionWest Valley City, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - West Virginia UniversityMorgantown, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07029399) ## Related records ### Drugs (2) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) ### Lead sponsors (1) - [NiKang Therapeutics, Inc.](https://trialight.com/data/company/nikang-therapeutics-inc-b764add5-764c-443c-a9af-6ff723cb414d.md) ### Conditions (2) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (2) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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