Skip to content

Phase I/Ib clinical study of the safety, tolerability, pharmacokinetics and preliminary efficacy and indication cohort expansion of the selective PI3Ka inhibitor RP903 (also known as JS105) in patients with advanced malignancies

Phase I/Ib clinical study of the safety, tolerability, pharmacokinetics and preliminary efficacy and indication cohort expansion of the selective PI3Ka inhibitor RP903 (also known as JS105) in patients with advanced malignancies

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063384
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-10-06
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

Intervention Group:Different doses RP903

Sponsors

Fudan University ShangHai Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Understand and voluntarily sign the informed consent; 2. Aged 18-75 (including 18 and 75), male and female; 3. You can swallow the whole pill;

Exclusion criteria

Exclusion criteria: 1. Patients with known allergies to RP903 components and patients with known allergies to fulvestrant are not able to enroll in phase Ib extended cohort 4 (breast cancer cohort); 2. Previous treatment with PI3K, mTOR or AKT inhibitors; 3. Participate in other clinical studies, unless observational (non-interventional), within 4 weeks before the first dose Follow-up period for bed study or intervention study; 4. Underwent major surgery or was in recovery from surgery or expected to be in research within 4 weeks before the first dose Major surgery during the study period;

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics;

Countries

China

Contacts

Public ContactJian Zhang/XiChun Hu

Fudan University ShangHai Cancer Hospital

xchu2009@hotmail.com+86 02164175590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026