Phase
Condition
Ovarian Cancer
Vaginal Cancer
Endometriosis
Treatment
RP903
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Agreement to provide fresh or archived tumor tissue sample within 3 years
Ia (dose escalation phase and dose expansion phase):patients with pathologicallyconfirmed 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 activatingmutations, experience treatment failure, are intolerant to standard treatment, orhave no standard treatment
Phase Ia: Solid tumour, not limited to specific types; dose expansion phase willprioritize cervix carcinoma, endometrial cancer, ovarian cancer, and breast cancer.
Phase Ib:Cervix carcinoma (Expanded Cohort 1):Having received first-line (includingPlatinum-based chemotherapy ± bevacizumab) or second-line treatment and havingdisease progression during or after treatment; (recurrence during or within 12months after neoadjuvant or adjuvant treatment in previous treatment will beregarded as one treatment line)
Phase Ib:Endometrial cancer (extension cohort 2):Progression during or afterfirst-line (including platinum) or second-line treatment of advanced or metastaticdisease; (recurrence during or within 12 months after neoadjuvant or adjuvanttreatment in previous treatment will be considered as one treatment line);Sarcomatype not included
Ovarian cancer (expanded cohort 3) (PIK3CA mutation):
Ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who haveexperienced treatment failure or are intolerant to at least one line of cytotoxictherapy ± PARP inhibitor; (recurrence during or within 12 months after neoadjuvantor adjuvant therapy will be considered one line of therapy)
Pathological types include high-grade serous carcinoma, clear cell carcinoma, orEndometrioid 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 whohave relapsed during or within 12 months after completion of neoadjuvant/adjuvantendocrine therapy will be considered as one line of endocrine therapy)
At least one measurable lesion as per RECIST v1.1 (except the dose-escalation phaseof monotherapy)
Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1
Adequate hematologic and organ function
Exclusion
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 ofcarcinomatous 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 IIDiabetes mellitus
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu,
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun,
ChinaActive - Recruiting
Jilin University First Hospital
Changchun,
ChinaActive - Recruiting
Sichuan Cancer Hospital
Chengdu,
ChinaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing,
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou,
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou,
ChinaActive - Recruiting
Sir Run Run Shaw Hospital
Hangzhou,
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou,
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin,
ChinaActive - Recruiting
Shandong Cancer Hospital & Institute
Jinan,
ChinaActive - Recruiting
Affiliated Hospital of Jining Medical College
Jining,
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi,
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang,
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning,
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao,
ChinaActive - Recruiting
Affiliated Cancer Hospital of Fudan University
Shanghai,
ChinaActive - Recruiting
Liaoning Cancer Hospital&Institute
Shenyang,
ChinaActive - Recruiting
Suining Central Hospital
Suining,
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan,
ChinaActive - Recruiting
Ceneral Hosipital of Ningxia Medical University
Yinchuan,
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou,
ChinaActive - Recruiting
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