Evaluating RP903 for advanced cancers

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

This study is testing a new drug called RP903 to see if it can help people with advanced cancers, like cervical or breast cancer, who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. (industry)
• Drugs / interventions: bevacizumab, chemotherapy
• Locations: 23 sites (Beijing and 22 other locations)
• Trial ID: NCT06846099 on ClinicalTrials.gov

What this trial studies

This open-label Phase I/Ib clinical study aims to assess the safety, tolerability, pharmacokinetics, and initial efficacy of RP903 in patients with advanced malignancies who have not responded to standard treatments. The study consists of two parts: Phase Ia focuses on dose escalation and extension to determine the maximum tolerated dose and pharmacokinetic profile, while Phase Ib expands to evaluate the drug's efficacy in specific cancers with PIK3CA mutations. Patients will receive RP903 as a single agent, and the study will prioritize those with cervical, endometrial, ovarian, and breast cancers based on prior treatment failures.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have experienced treatment failure or are intolerant to standard therapies, particularly those with PIK3CA mutations.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers who have limited or no standard treatment alternatives.

How similar studies have performed: Other studies targeting PIK3CA mutations in advanced cancers have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Beijing and 22 other locations

• Beijing Cancer Hospital — Beijing, China (RECRUITING)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (RECRUITING)
• Jilin Cancer Hospital — Changchun, China (RECRUITING)
• Jilin University First Hospital — Changchun, China (RECRUITING)
• Sichuan Cancer Hospital — Chengdu, China (RECRUITING)
• Chongqing University Cancer Hospital — Chongqing, China (RECRUITING)
• Fujian Cancer Hospital — Fuzhou, China (RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, China (RECRUITING)
• Sir Run Run Shaw Hospital — Hangzhou, China (RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, China (RECRUITING)
• Shandong Cancer Hospital & Institute — Jinan, China (RECRUITING)
• Affiliated Hospital of Jining Medical College — Jining, China (RECRUITING)
• Linyi Cancer Hospital — Linyi, China (RECRUITING)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China (RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, China (RECRUITING)
• Affiliated Cancer Hospital of Fudan University — Shanghai, China (RECRUITING)
• Liaoning Cancer Hospital&Institute — Shenyang, China (RECRUITING)
• Suining Central Hospital — Suining, China (RECRUITING)
• Hubei Cancer Hospital — Wuhan, China (RECRUITING)
• Ceneral Hosipital of Ningxia Medical University — Yinchuan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Jie Wang, PM

Conditions: Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Breast Cancer, Solid Tumor Cancer