A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903
NCT ID: NCT06846099
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2022-12-07
2025-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RP903 arm
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Risen (Suzhou) Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Jilin Cancer Hospital
Changchun, , China
Jilin University First Hospital
Changchun, , China
Sichuan Cancer Hospital
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Shandong Cancer Hospital & Institute
Jinan, , China
Affiliated Hospital of Jining Medical College
Jining, , China
Linyi Cancer Hospital
Linyi, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Guangxi Medical University Cancer Hospital
Nanning, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Affiliated Cancer Hospital of Fudan University
Shanghai, , China
Liaoning Cancer Hospital&Institute
Shenyang, , China
Suining Central Hospital
Suining, , China
Hubei Cancer Hospital
Wuhan, , China
Ceneral Hosipital of Ningxia Medical University
Yinchuan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JS105-001-I
Identifier Type: -
Identifier Source: org_study_id