NCT06846099

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

A Phase I/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of Pl3Kα-Selective Inhibitor RP903 (JS105) in Subjects With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Phase Ia is divided into two phases of dose escalation and dose extension: This part includes dose escalation and dose extension of RP903 single agent to investigate the safety, tolerability, maximum tolerated dose and pharmacokinetic (PK) characteristics of RP903 single agent. Phase Ib is the clinical indication expansion phase, and the primary purpose of this phase is to evaluate the initial safety and anti-tumor efficacy in a selected indication target population. After determining RP903 monotherapy RP2D in Phase Ia, SMC will select four advanced malignant tumors with PIK3CA mutations (cervical cancer, endometrial cancer, breast cancer, and ovarian cancer) as indications for clinical expansion studies based on phase Ia efficacy, safety, and pharmacokinetic (PK) data. The dose was determined according to the results of the dose escalation phase and the dose extension phase.

Conditions

• Ovarian Cancer
• Cervical Cancer
• Endometrial Cancer
• Breast Cancer
• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	RP903	Ia:RP903 50mg, 100mg, 200mg, 300mg,350mg,or other dose, po qd for each 28-day cycle； Ib: RP903,RP2D,po qd for each 28-day cycle

Timeline

• Start date: 2022-12-07
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2025-02-25
• Last updated: 2025-12-23

Locations

23 sites across 1 country: China

Regulatory

• FDA-regulated drug study