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

NCT06846099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-12-23

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Risen (Suzhou) Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846099 on ClinicalTrials.gov