NCT05128487

A Study of NDI 1150-101 in Patients With Solid Tumors

A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination With Pembrolizumab in Patients With Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Nimbus Saturn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Solid Tumor
• Renal Cell Carcinoma (Kidney Cancer)
• Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	NDI-101150	NDI-101150 capsules
DRUG	Pembrolizumab	Pembrolizumab IV infusion

Timeline

• Start date: 2021-11-05
• Primary completion: 2025-02-01
• Completion: 2025-05-01
• First posted: 2021-11-22
• Last updated: 2024-11-25

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study