NCT06739291

A Study of SIGX1094R in Patients With Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Anti-tumor Activity and Food Effect of SIGX1094R in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Signet Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I clinical, first-in-human study of SIGX1094R monotherapy. The goal of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), anti-tumor activity and food effect of SIGX1094R in patients with advanced solid tumors.

Detailed description

The study consists of two parts: SIGX1094R dose escalation study; food effect and SIGX1094R multiple-dose expansion study. Part of SIGX1094R dose escalation study: * the primary objective is to evaluate the safety and tolerability of SIGX1094R, and to define the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). * the secondary objective is to evaluate the PK profile and preliminary efficacy of SIGX1094R, and to explore the relationship between PD parameters and efficacy. Part of food effect and SIGX1094R multiple-dose expansion study: * the primary objective is to evaluate the food effect on PK profile of SIGX1094R. * the secondary objective is to further evaluate the anti-tumor activity, safety and tolerability of SIGX1094R, and to further evaluate the relationship between PD parameters and efficacy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SIGX1094R	Single drug treatment by SIGX1094R, orally administered once daily.

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2024-12-18
• Last updated: 2025-09-08

Locations

1 site across 1 country: China