AzTrials
AzTrials

Ovarian CancerPhase 1NCT06846099

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

A Phase 1 study testing RP903 in people with Ovarian Cancer and Cervical Cancer, run by Risen (Suzhou) Pharma Tech Co., Ltd. at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RP903
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
23 sitesChina
Study dates
7 Dec 2022to 30 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Beijing Cancer Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Jilin Cancer Hospital

    Changchun

  • Jilin University First Hospital

    Changchun

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • Fujian Cancer Hospital

    Fuzhou

  • Fujian Medical University Union Hospital

    Fuzhou

  • Sir Run Run Shaw Hospital

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Shandong Cancer Hospital & Institute

    Jinan

  • Affiliated Hospital of Jining Medical College

    Jining

  • Linyi Cancer Hospital

    Linyi

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

    Luoyang

  • Guangxi Medical University Cancer Hospital

    Nanning

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Affiliated Cancer Hospital of Fudan University

    Shanghai

  • Liaoning Cancer Hospital&Institute

    Shenyang

  • Suining Central Hospital

    Suining

  • Hubei Cancer Hospital

    Wuhan

  • Ceneral Hosipital of Ningxia Medical University

    Yinchuan

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

Official title: 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

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).

Read the detailed 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.

Being tested
RP903
Medical subject headings
Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RP903Drug

    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

Study groups in NCT06846099
Study groupRoleWhat they receive
RP903 armExperimentalIa: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
Receives: Drug: RP903

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ia:dose-limiting toxicity(DLTs)

    Incidence and severity of dose-limiting toxicity (DLTs)

    Measured: 28 days

  2. Ia:Adverse Events

    Incidence and severity of Adverse Events(AEs) according to NCI-CTCAE

    Measured: 2 years

  3. Ia: serious adverse events

    Incidence and severity of serious adverse events(SAEs) according to NCI-CTCAE

    Measured: 2 years

  4. Ia: Abnormal changes in Laboratory test and other abnormalities

    Incidence and severity of abnormal changes in Laboratory test and other tests with clinically significant according to NCI-CTCAE

    Measured: 2 years

  5. Ia: MTD

    Maximum Tolerated Dose(MTD)

    Measured: 2 years

  6. Ia: MAD

    Maximum Administrated Dose(MAD)

    Measured: 2 years

  7. Ia:RP2D

    Recommended Phase II Dose(RP2D)

    Measured: 2 years

  8. Ib:objective response rate(ORR);

    Efficacy evaluated by the investigator according to RECIST v1.1: objective response rate (ORR);

    Measured: 2 years

  9. Ib:AE

    Type, frequency, duration, severity and characteristics of Adverse Events (AEs) according to NCI-CTCAE

    Measured: 2 years

  10. Ib:SAE

    Type, frequency, duration, severity and characteristics of serious adverse events(SAEs) according to NCI-CTCAE

    Measured: 2 years

Secondary outcomes (32)

  1. Ia:the concentration of RP903 or its metabolites (if applicable)

    the concentration of RP903 or its metabolites (if applicable) in individual subjects at different time points after administration;

    Measured: 1 years

  2. Ia:Cmax

    peak concentration

    Measured: 1 years

  3. Ia:Ctrough

    trough concentration

    Measured: 1 years

  4. Ia:Tmax

    time to peak

    Measured: 1 years

  5. Ia:AUC0-t and AUC0-∞

    area under the plasma drug concentration-time curve

    Measured: 1 years

  6. Ia:Vd/F

    distribution volume

    Measured: 1 years

  7. Ia:CL/F

    clearance

    Measured: 1 years

  8. Ia:t1/2

    half-life

    Measured: 1 years

  9. Ia:Rac

    cumulative factor

    Measured: 1 years

  10. Ia:ORR

    objective response rate

    Measured: 1 years

  11. Ia:DoR

    duration of response

    Measured: 1 years

  12. Ia:DCR

    disease control rate

    Measured: 1 years

  13. Ia:TTR

    time to response

    Measured: 1 years

  14. Ia:PFS

    progression-free survival

    Measured: 1 years

  15. Ia:OS

    overall survival

    Measured: 1 years

  16. Ib:safety:AE

    Type, frequency, duration, severity and characteristics of serious adverse events(SAEs) according to NCI-CTCAE

    Measured: 2 years

  17. Ib:safety:SAE

    Type, frequency, duration, severity and characteristics of serious adverse events(SAEs) according to NCI-CTCAE

    Measured: 2 years

  18. Ib:safety:Body temperature

    Body temperature changes according to NCI-CTCAE

    Measured: 2 years

  19. Ib:safety:pulse

    pulse changes according to NCI-CTCAE

    Measured: 2 years

  20. Ib:safety:respiratory rate

    respiratory rate changes according to NCI-CTCAE

    Measured: 2 years

  21. Ib:safety: blood pressure

    blood pressure changes according to NCI-CTCAE

    Measured: 2 years

  22. Ib:safety:laboratory test

    laboratory test changes according to NCI-CTCAE

    Measured: 2 years

  23. Ib:safety:heart rate

    heart rate changes according to NCI-CTCAE

    Measured: 2 years

  24. Ib:safety:QT

    QT changes according to NCI-CTCAE

    Measured: 2 years

  25. Ib:safety:QTcF

    QTcF changes according to NCI-CTCAE

    Measured: 2 years

  26. Ib:safety:PR

    PR changes according to NCI-CTCAE

    Measured: 2 years

  27. Ib:DoR

    duration of response

    Measured: 1 years

  28. Ib:DCR

    disease control rate

    Measured: 1 years

  29. Ib:TTR

    time to response

    Measured: 1 years

  30. Ib:PFS

    progression-free survival

    Measured: 1 years

  31. Ib:OS

    overall survival

    Measured: 2 years

  32. Ib:Concentrations of RP903 or its metabolites

    Concentrations of RP903 or its metabolites (if applicable) in individual subjects at different time points after dosing.

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start7 Dec 2022
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
once daily on Days 1-28 of each 28-day cycle
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846099
Sponsor's protocol ID
JS105-001-I
Status last verified
Dec 2025
First submitted
19 Jan 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RP903 in people with Ovarian Cancer and Cervical Cancer, run by Risen (Suzhou) Pharma Tech Co., Ltd. at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ia:dose-limiting toxicity(DLTs) (time frame: 28 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06846099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in