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New pill shows promise for Hard-to-Treat cancers in early trial

NCT ID NCT06846099

Disease control Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called RP903 in 69 people with advanced solid tumors (like ovarian, breast, or cervical cancer) who had run out of standard options. The main goals were to check safety, find the best dose, and see if the drug shrinks tumors. It is an early-phase trial, so results will guide future studies rather than offer a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

69 people

The number who actually took part.

Started

Dec 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cancer cervical cancer endometrial cancer endometrium neoplasm ovarian cancer Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Cervical cancer Endometrial cancer Ovarian cancer Solid tumor cancer

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Fudan University

    Shanghai, China

  • Affiliated Hospital of Jining Medical College

    Jining, China

  • Beijing Cancer Hospital

    Beijing, China

  • Ceneral Hosipital of Ningxia Medical University

    Yinchuan, China

  • Chongqing University Cancer Hospital

    Chongqing, China

  • Fujian Cancer Hospital

    Fuzhou, China

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • Guangxi Medical University Cancer Hospital

    Nanning, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Jilin Cancer Hospital

    Changchun, China

  • Jilin University First Hospital

    Changchun, China

  • Liaoning Cancer Hospital&Institute

    Shenyang, China

  • Linyi Cancer Hospital

    Linyi, China

  • Shandong Cancer Hospital & Institute

    Jinan, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • Sir Run Run Shaw Hospital

    Hangzhou, China

  • Suining Central Hospital

    Suining, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, China

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

    Luoyang, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

More trials for these conditions

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