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ACTIVE NOT RECRUITING
NCT05128487
PHASE1/PHASE2

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

Sponsor: Nimbus Saturn, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2021-11-05

Completion Date

2025-05

Last Updated

2024-11-25

Healthy Volunteers

No

Interventions

DRUG

NDI-101150

NDI-101150 capsules

DRUG

Pembrolizumab

Pembrolizumab IV infusion

Locations (19)

Honor Health Research Institute

Scottsdale, Arizona, United States

Yale Cancer Center

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Ocala Oncology Center

Ocala, Florida, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Henry Ford Cancer

Detroit, Michigan, United States

HealthPartners Cancer Research Center

Saint Paul, Minnesota, United States

Washington University

St Louis, Missouri, United States

Hackensack University

Hackensack, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Center for Oncology and Blood Disorders

Houston, Texas, United States

Oncology Consultants

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States