This is a multicenter, open-label, two-part, first-in-human, Phase 1/2 study.~In this 2 part study, eligible patients will be enrolled in Part 1 (Dose Escalation Phase: designed to evaluate the safety and tolerability of NDI-101150 as monotherapy and in combination with pembrolizumab) and Part 2 (Dose Expansion Phase: designed to evaluate the safety and efficacy of NDI-101150 as monotherapy and in combination with pembrolizumab in disease-specific (gastric and gastroesophageal junction [GEJ] cancer) dose expansion cohorts).~Each part of the study will consist of 3 phases:~A Screening Phase of up to 28 days during which patient eligibility will be reviewed and approved by the Sponsor.~Treatment Phase that will extend from Cycle 1 Day 1 until progression of disease (PD), unacceptable toxicity, withdrawal of consent, start of a new systemic anticancer treatment, discontinuation of the patient by the Investigator, or termination of the study by the Sponsor (and will include Safety Follow-up Visit 30 days [+3 days] after the last dose of investigational medicinal product).~Post treatment Follow-up Phase which will continue until lost to follow-up, withdrawal of consent, or the End of the Study (whichever comes first).
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors.