Status and phase
Conditions
Treatments
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
106 participants in 2 patient groups
Loading...
Central trial contact
Study Coordinator
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal