A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
NCT ID: NCT07029399
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
205 participants
INTERVENTIONAL
2025-03-25
2027-12-31
Brief Summary
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* What is the recommended dose for expansion and/or Phase 2
* What medical issues/symptoms do participants experience when taking NKT5097
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Escalation of orally administered NKT5097
NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Part 2 Food Effect
Orally administered NKT5097 with and without meal
NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Part 3 Expansion
Expansion of dose levels based upon safety and PK following Part 1 escalation.
NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Interventions
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NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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NiKang Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Dana Faber Institutional clinical.gov contact
Role: primary
Other Identifiers
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NKT5097-101
Identifier Type: -
Identifier Source: org_study_id
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