A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903

Last updated: February 20, 2025
Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Ovarian Cancer

Vaginal Cancer

Endometriosis

Treatment

RP903

Clinical Study ID

NCT06846099
JS105-001-I
  • Ages 18-75
  • All Genders

Study Summary

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).

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

Total Participants: 174
Treatment Group(s): 1
Primary Treatment: RP903
Phase: 1
Study Start date:
December 07, 2022
Estimated Completion Date:
December 31, 2025

Study Description

Phase Ia is divided into two phases of dose escalation and dose extension: This part includes dose escalation and dose extension of RP903 single agent to investigate the safety, tolerability, maximum tolerated dose and pharmacokinetic (PK) characteristics of RP903 single agent.

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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu,
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun,
    China

    Active - Recruiting

  • Jilin University First Hospital

    Changchun,
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu,
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Active - Recruiting

  • Shandong Cancer Hospital & Institute

    Jinan,
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical College

    Jining,
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang,
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Liaoning Cancer Hospital&Institute

    Shenyang,
    China

    Active - Recruiting

  • Suining Central Hospital

    Suining,
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan,
    China

    Active - Recruiting

  • Ceneral Hosipital of Ningxia Medical University

    Yinchuan,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

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