NCT06403436

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: TOLREMO therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.

Detailed description

The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.

Conditions

• Advanced Solid Tumor
• Adult Solid Tumor
• Adult Disease
• Cancer
• NSCLC
• EGFR
• KRAS G12C
• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TT125-802	TT125-802 administered orally

Timeline

• Start date: 2023-11-07
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-05-07
• Last updated: 2026-04-13

Locations

7 sites across 3 countries: United States, Spain, Switzerland

Regulatory

• FDA-regulated drug study