A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903

Phase 1 Completed 69 enrolled Risen (Suzhou) Pharma Tech Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This is an open phase I/Ib clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and initial efficacy of RP903 in patients with advanced malignancies who have failed standard treatment or have no standard treatment options. The study was divided into two parts: dose escalation and dose extension (Phase Ia) and clinical extension (Phase Ib).

Timeline

Start: 2022-12-07
Primary completion: 2025-05-30
Completion: 2025-05-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RP903	Unknown	50 mg	Oral
Subject	RP903	Unknown	100 mg	Oral
Subject	RP903	Unknown	200 mg	Oral
Subject	RP903	Unknown	300 mg	Oral
Subject	RP903	Unknown	350 mg	Oral