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

NCT06846099 | Completed Phase 1 FDA Drug

• 1 other identifier: JS105-001-I
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 23

Brief 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

Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Breast Cancer; Solid Tumor Cancer

Outcome Measures

Primary Outcomes (10)

• Ia:dose-limiting toxicity(DLTs)

  Incidence and severity of dose-limiting toxicity (DLTs)

  28 days

• Ia:Adverse Events

  Incidence and severity of Adverse Events(AEs) according to NCI-CTCAE

  2 years

• Ia: serious adverse events

  Incidence and severity of serious adverse events(SAEs) according to NCI-CTCAE

  2 years

• Ia: Abnormal changes in Laboratory test and other abnormalities

  Incidence and severity of abnormal changes in Laboratory test and other tests with clinically significant according to NCI-CTCAE

  2 years

• Ia: MTD

  Maximum Tolerated Dose(MTD)

  2 years

• Ia: MAD

  Maximum Administrated Dose(MAD)

  2 years

• Ia:RP2D

  Recommended Phase II Dose(RP2D)

  2 years

• Ib:objective response rate(ORR);

  Efficacy evaluated by the investigator according to RECIST v1.1: objective response rate (ORR);

  2 years

• Ib:AE

  Type, frequency, duration, severity and characteristics of Adverse Events (AEs) according to NCI-CTCAE

  2 years

• Ib:SAE

  Type, frequency, duration, severity and characteristics of serious adverse events(SAEs) according to NCI-CTCAE

  2 years

Secondary Outcomes (32)

• Ia:the concentration of RP903 or its metabolites (if applicable)

  1 years

• Ia:Cmax

  1 years

• Ia:Ctrough

  1 years

• Ia:Tmax

  1 years

• Ia:AUC0-t and AUC0-∞

  1 years

Other Outcomes (5)

• blood glucose

  28days

• Insulin

  28days

• C-peptide

  28days

Study Arms (1)

RP903 arm

EXPERIMENTAL

Ia:Participants will receive RP903 in escalating dose levels with starting dose of 50mg, po qd for each 28-day cycle Ib:Participants will receive RP903 with RP2D, po qd for each 28-day cycle

Drug: RP903

Interventions

RP903 DRUG

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

RP903 arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement to provide fresh or archived tumor tissue sample within 3 years
• Ia (dose escalation phase and dose expansion phase):patients with pathologically confirmed advanced Malignant solid tumour who have experienced Treatment failure, are unable to tolerate standard treatment, or have no standard treatment
• Ib: Patients with advanced malignant solid tumours who have PIK3CA activating mutations, experience treatment failure, are intolerant to standard treatment, or have no standard treatment
• Phase Ia: Solid tumour, not limited to specific types; dose expansion phase will prioritize cervix carcinoma, endometrial cancer, ovarian cancer, and breast cancer.
• Phase Ib:Cervix carcinoma (Expanded Cohort 1)：Having received first-line (including Platinum-based chemotherapy ± bevacizumab) or second-line treatment and having disease progression during or after treatment; (recurrence during or within 12 months after neoadjuvant or adjuvant treatment in previous treatment will be regarded as one treatment line)
• Phase Ib:Endometrial cancer (extension cohort 2)：Progression during or after first-line (including platinum) or second-line treatment of advanced or metastatic disease; (recurrence during or within 12 months after neoadjuvant or adjuvant treatment in previous treatment will be considered as one treatment line)；Sarcoma type not included
• Ovarian cancer (expanded cohort 3) (PIK3CA mutation)：
• Ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who have experienced treatment failure or are intolerant to at least one line of cytotoxic therapy ± PARP inhibitor; (recurrence during or within 12 months after neoadjuvant or adjuvant therapy will be considered one line of therapy)
• Pathological types include high-grade serous carcinoma, clear cell carcinoma, or Endometrioid carcinoma
• Breast cancer (extension cohort 4) (PIK3CA mutation)：
• Advanced, recurrent and metastatic breast cancer;
• Prior systemic treatment in at least 1 line and no more than 3 lines (patients who have relapsed during or within 12 months after completion of neoadjuvant/adjuvant endocrine therapy will be considered as one line of endocrine therapy)
• At least one measurable lesion as per RECIST v1.1 (except the dose-escalation phase of monotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1
• Adequate hematologic and organ function

You may not qualify if:

• Patients with known allergy to any component of RP903
• Previously treated with PI3K, mTOR or AKT inhibitors
• Systemic anti-tumor therapy within 4 weeks prior to the first dose
• Presence of leptomeningeal or meningeal metastasis, or presence of signs of carcinomatous Meningitis
• Metastases to bone marrow
• Child-Pugh grade B or C
• Active hepatitis B or C
• History of type I Diabetes mellitus，gestational diabetes or uncontrolled type II Diabetes mellitus

Sponsors & Collaborators

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

Study Sites (23)

Beijing Cancer Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Jilin Cancer Hospital

Changchun, China

Location

Jilin University First Hospital

Changchun, China

Location

Sichuan Cancer Hospital

Chengdu, China

Location

Chongqing University Cancer Hospital

Chongqing, China

Location

Fujian Cancer Hospital

Fuzhou, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

Sir Run Run Shaw Hospital

Hangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Shandong Cancer Hospital & Institute

Jinan, China

Location

Affiliated Hospital of Jining Medical College

Jining, China

Location

Linyi Cancer Hospital

Linyi, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

Guangxi Medical University Cancer Hospital

Nanning, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Affiliated Cancer Hospital of Fudan University

Shanghai, China

Location

Liaoning Cancer Hospital&Institute

Shenyang, China

Location

Suining Central Hospital

Suining, China

Location

Hubei Cancer Hospital

Wuhan, China

Location

Ceneral Hosipital of Ningxia Medical University

Yinchuan, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: once daily on Days 1-28 of each 28-day cycle

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 25, 2025
• Study Start: December 7, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)