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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.
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
Jilin University First Hospital
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ChangchunChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Sir Run Run Shaw Hospital
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Shandong Cancer Hospital & institute
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JinanChinaUnknown status
Affiliated Hospital of Jining Medical College
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JiningChinaUnknown status
LinYi Cancer Hospital
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LinyiChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
Guangxi Medical University Cancer Hospital
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NanningChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Affiliated Cancer Hospital of Fudan University
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital & Institute
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ShenyangChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
Ceneral Hosipital of Ningxia Medical University
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YinchuanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.