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

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 effectivecontraception and to refrain from sperm donation during treatment and for 28 daysafter 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 localbasal cell or squamous carcinoma of the skin, in situ cervical cancer, adequatelytreated papillary noninvasive bladder cancer, other adequately treated Stage I orStage 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)