NCT05551507
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
Notable Eligibility criteria expanded, about 38 words Show 4 more changesShow less
- Enrollment closed, study ongoing
- Study completion pushed from Sep 30, 2026 to Dec 31, 2026
- Primary completion date changed from estimate of May 31, 2026 to May 11, 2026
- Site details revised at 7 of 7 sites
- Minor Primary completion date: Dec 31, 2025 to May 31, 2026
- Study completion date: Dec 31, 2025 to Sep 30, 2026
- Notable Primary and study completion dates pushed to Dec 31, 2025v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Timeframe: Up to 24 months
Recommended phase 2 dose (RP2D) of the combination.
Timeframe: Up to 2 months
Objective response rate (ORR) as assessed by investigator.
Timeframe: Up to 24 months
Secondary (6)
Objective response rate (ORR) as assessed by blinded independent central review (BICR).
Duration of response (DOR) as assessed by investigator and BICR.
Disease control rate (DCR) as assessed by investigator and BICR.
Progression free survival (PFS) as assessed by investigator and BICR.
Overall survival (OS)
Show 1 moreShow less
CA 125 response rate per Gynecological Cancer Inter-group (GCIG) criteria.
Arms and interventions
IN10018 in combination with PLDExperimental
IN10018 in combination with PLD in platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma subjects.
Drugs: IN10018 in combination with PLD
Sites
7 sites in 1 country