Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer

Phase 1

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: NMS-03305293; Drug: Topotecan

• Registration Number: NCT06930755
• Lead Sponsor: Nerviano Medical Sciences

Brief Summary

This is a multicenter, open-label Phase Ia/b study on the safety and efficacy of the combination of NMS-03305293 and topotecan in patients with recurrent ovarian cancer, with dose-limiting toxicity (DLT) escalation. The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with topotecan.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-06-28
• Primary Completion: 2026-09-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NMS-03305293 and Topotecan	NMS-03305293	NMS-03305293 will be administered orally, twice daily, on a 1-7-day schedule, in repeated 4-week cycles (i.e., 28 days). Topotecan will be administered intravenously (IV), once weekly, on Days 1, 8, and 15, of Weeks 1-3, in repeated 4-week cycles (i.e., 28 days) at 4 mg/m\^2 with maximum dose of 4 mg.
NMS-03305293 and Topotecan	Topotecan	NMS-03305293 will be administered orally, twice daily, on a 1-7-day schedule, in repeated 4-week cycles (i.e., 28 days). Topotecan will be administered intravenously (IV), once weekly, on Days 1, 8, and 15, of Weeks 1-3, in repeated 4-week cycles (i.e., 28 days) at 4 mg/m\^2 with maximum dose of 4 mg.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 6 months)	Evaluation of type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 5.0), duration of AEs, electrocardiogram (ECG) and laboratory abnormalities

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	From the date of first response up to data cut-off (approximately 22 months)	Duration of response will be calculated from the date of either first CR or PR until the date of documented progression for patients who achieved CR or PR. Patients who died without report of progression will be considered non-events and censored at their last disease-free assessment date
Progression-free survival (PFS)	From the date of treatment initiation up to data cut-off (approximately 24 months)	Progression Free Survival will be calculated from the date of treatment initiation to the date of first documentation of disease progression, or death due to any cause, whichever occurs first
Overall survival (OS)	From the date of treatment initiation up to data cut-off (approximately 24 months)	Overall Survival will be calculated from the date of treatment initiation to the date of death due to any cause
Overall Response Rate (ORR)	From the date of first response up to data cut-off (approximately 22 months)	Calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), complete response (CR) or partial response (PR) through Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Plasma pharmacokinetic profile of NMS-03305293 after oral administration	Cycle 1 - Days 1, 2, 5 and 6; Cycle 2 - Days 1 & 5. Each cycle is 28 days