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

Solid Tumor Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT05128487
• Study type: Interventional
• Source: Nimbus Therapeutics
• Contact: Study Coordinator
• Phone: 8579992009
• Email: clinical@nimbustx.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 5, 2021
• Completion date: December 2024