NCT06846099CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 19 Jan 2025
- Start date
- 7 Dec 2022
- Primary completion date
- 30 May 2025
- Lead sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
- Diseases
- Endometrial cancer, Cervical cancer, Ovarian cancer
- NCT number
- NCT06846099
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 69
- From 7 Dec 2022 to the primary completion date, 30 May 2025
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously treated with PI3K, mTOR or AKT inhibitors
- Systemic anti-tumor therapy within 4 weeks prior to the first dose
Other illness
- Patients with known allergy to any component of RP903
- Active hepatitis B or C
- History of type I Diabetes mellitus,gestational diabetes or uncontrolled type II Diabetes mellitus
Other
- Presence of leptomeningeal or meningeal metastasis, or presence of signs of carcinomatous Meningitis
- Metastases to bone marrow
- Child-Pugh grade B or C
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Jilin University First Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Shandong Cancer Hospital & institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Affiliated Hospital of Jining Medical College Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Affiliated Cancer Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Ceneral Hosipital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.