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NDI-101150 in Advanced Solid Tumors
NCT05128487Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2021
- Primary completion
- Feb 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- NDI-101150
- Conditions
- solid tumorrenal cell carcinoma (RCC)gastric adenocarcinomagastroesophageal junction adenocarcinomanon-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label trial of NDI-101150 in solid tumor, renal cell carcinoma (RCC), gastric adenocarcinoma and 2 more (2 arms). Primary endpoints: Frequency of Dose-Limiting Toxicities and Objective Response Rate up to 34 months. Started Nov 2021; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
NDI-101150 Monotherapy
NDI-101150 capsules orally once daily
NDI-101150 + Pembrolizumab
NDI-101150 capsules orally once daily + Pembrolizumab 200 mg IV every 3 weeks
03
Who it enrols
Adult patients with advanced solid tumors (specifically RCC, NSCLC, Gastric/GEJ for expansion) who have progressed on or are intolerant to standard therapies, with ECOG 0-1 and adequate organ function.
04
Endpoints
Primary
Frequency of Dose-Limiting Toxicities
Objective Response Rate
Secondary
Adverse Events
Maximum Plasma Concentration
Time to Maximum Plasma Concentration
Area Under the Concentration-Time Curve (0-t)
Area Under the Concentration-Time Curve (0-inf)
Objective Response Rate (Part 1)
Progression-Free Survival
Duration of Response
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