Finding studies
Finding studies
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Lead
Nimbus Saturn, Inc.
This is a multicenter, open-label, first-in-human, Phase 1/2 study. The study will consist of 2 phases: * The Dose Escalation Phase: designed to evaluate the safety and tolerability of NDI-101150 as monotherapy (Arm 1) and in combination with pembrolizumab (Arm 2) in patients with advanced solid tumors. * The Dose Expansion Phase: designed to evaluate the safety and efficacy of NDI-101150 as monotherapy (Arm 1) and in combination with pembrolizumab (Arm 2) in disease-specific dose expansion cohorts: gastric and gastroesophageal junction \[GEJ\] cancer, non-small cell lung cancer \[NSCLC\], and renal cell carcinoma \[RCC\]. Each phase of the study will consist of 3 periods: * A Screening period of up to 28 days during which patient eligibility will be reviewed and approved by the Sponsor. * Treatment period 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. This will also include Safety Follow-up Visit 30 days \[+3 days\] after the last dose of investigational medicinal product. * Post treatment Follow-up period which will continue until lost to follow-up, withdrawal of consent, or the End of the Study (whichever comes first).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
