A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

Bookmark
Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (other)

Phase: 2

Start date: Feb. 6, 2025

Planned enrollment: 18

Trial ID: NCT06617923
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: Senaparib (IMP4297, Paishuning)

TrialFetch AI Analysis

Goal: Evaluate the antitumor activity of senaparib plus temozolomide in recurrent or persistent ARID1A-mutated clear cell or endometrioid ovarian cancer.

Patients: Adults assigned female at birth with recurrent or persistent ovarian, fallopian tube, or primary peritoneal carcinoma containing at least 50% clear cell or endometrioid morphology, a pathogenic or likely pathogenic ARID1A variant, and RECIST-measurable disease. Patients must have received at least two prior cytotoxic regimens or have platinum-resistant or platinum-refractory disease, with no more than three prior cytotoxic lines. Prior PARP inhibitor or temozolomide treatment is excluded.

Design: Multicenter, single-arm, nonrandomized, two-stage phase 2 study. Treatment continues until progression, unacceptable toxicity, or withdrawal of consent.

Treatments: Senaparib 80 mg orally on days 1–28 plus temozolomide 20 mg orally on days 1–21 of each 28-day cycle. Senaparib inhibits the DNA-repair enzymes PARP1 and PARP2, potentially increasing tumor-cell vulnerability to DNA damage. In a separate phase 3 ovarian cancer maintenance trial, senaparib improved progression-free survival versus placebo; in an early-phase solid-tumor study, 10 of 44 evaluable patients had a partial response. Neither result establishes efficacy for this combination or ARID1A-mutated population. Temozolomide is an oral DNA-alkylating agent.

Outcomes: The primary endpoint is objective response rate, defined as complete or partial response by RECIST v1.1. Secondary endpoints characterize treatment-related adverse events, including grade 3 and 4 events, using CTCAE v5.0.

Burden on patient: Moderate. Both drugs are taken at home, but dosing is daily or near-daily, with tumor assessments every 8 weeks during the first three cycles and every 12 weeks thereafter. Repeated safety assessments and visits are expected, although the protocol does not describe mandatory research biopsies or intensive pharmacokinetic blood sampling.

Last updated: Sep 2026

Eligibility More information

chevron Show Criteria

Sites (2)

Sort by distance to:
Clear

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

[email protected] / 410-955-8804

Status: Recruiting

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

[email protected] / 215-662-2419

Status: Recruiting

Back to trials list