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Trial NCT07029399

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Phase
Phase 1
Sponsor
NiKang Therapeutics, Inc.
Conditions
HR+ Breast Cancer; Triple Negative Breast Cancer (TNBC); CCNE1 Amplified Advanced Solid Tumors; HR+ HER2- Breast Cancer
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 1Performance status * 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 followingPrior malignancy: 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 monthsCardiac * Known active CNS metastases and/or carcinomatous meningitisBrain metastases * 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)Hepatic * Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)

Restrictions found (5)

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute · Boston, Suffolk County