A Study of NDI 1150-101 in Patients With Solid Tumors
NCT05128487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2024-11-25
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.
Conditions
- Solid Tumor
- Renal Cell Carcinoma (Kidney Cancer)
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- Non-Small Cell Lung Cancer
Interventions
- DRUG
-
NDI-101150
NDI-101150 capsules
- DRUG
-
Pembrolizumab IV infusion
Sponsors & Collaborators
-
Nimbus Saturn, Inc.
lead INDUSTRY
Principal Investigators
-
Anita Scheuber, MD · Nimbus Saturn
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-05
- Primary Completion
- 2025-02-28
- Completion
- 2025-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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