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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
NCT07029399 · NiKang Therapeutics, Inc.
In plain English
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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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 205 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-25
Estimated completion: 2027-12-31
Last updated: 2026-03-12
Interventions
Drug: NKT5097 CDK2/CDK4 dual degrader
Primary outcomes
- • Incidence of dose-limiting toxicities as Assessed by CTCAE (From enrollment through end of safety monitoring period of 28 days from first dose)
Sponsor
NiKang Therapeutics, Inc. · industry
Contacts & investigators
ContactSponsor Contact · contact · clinicaltrials@nikangtx.com · 302-596-8654
All locations (14)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Sarah Cannon Research Institute at HealthONERecruiting
Denver, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
SCRI Florida Cancer Specialists - SarasotaRecruiting
Sarasota, Florida, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics (START) MidwestRecruiting
Grand Rapids, Michigan, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START) San AntonioRecruiting
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START) Mountain RegionRecruiting
West Valley City, Utah, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States