Actively Recruiting
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Led by NiKang Therapeutics, Inc. · Updated on 2026-03-12
205
Participants Needed
14
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 * What medical issues/symptoms do participants experience when taking NKT5097
CONDITIONS
Official Title
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Advanced solid tumor that is a candidate for curative treatment
- History of another malignancy except for 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
13
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
14
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sponsor Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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