NCT05764915

A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Regor Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of RGT-264 as monotherapy in subjects with advanced solid tumors.

Detailed description

This first-in-human (FIH) study of RGT-264 will evaluate safety, pharmacokinetics (PK) and efficacy of RGT-264 in subjects with advanced solid tumors. The primary objective is to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D) of RGT-264 as monotherapy, and to evaluate the safety and tolerability of RGT-264. The secondary objectives include the assessments of PK profile and preliminary efficacy of RGT-264.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RGT-264 phosphate tablets	RGT-264 phosphate tablets will be administered orally once daily (QD).

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2023-03-13
• Last updated: 2024-08-01

Locations

3 sites across 1 country: China