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
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)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
within 6 months
Show in the text - HepaticOutrightexclusion
Child Pugh class B or C
Show in the text - Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County