Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 12:26 AM
Study NCT ID:
NCT07462468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
Sponsor:
WestVac Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, Single-arm, Single-center, Open-label, Prospective Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1, single-arm, single-center, open-label, prospective, dose-escalation, and cohort expansion study to assess the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of WSK-IM02 administered as a single agent to patients with platinum-resistant recurrent ovarian cancer.
Detailed Description:
Dose-escalation part of this study will assess the safety, tolerability, PK, and preliminary efficacy of WSK-IM02 as monotherapy in eligible patients with platinum-resistant recurrent ovarian cancer. Cohort expansion part will further evaluate the Recommended Phase 2 Dose (RP2D) of WSK-IM02. RP2D decisions will be based on the totality of data, including Dose-Limiting Toxicities (DLTs), tolerability, PK, pharmacodynamics (PD), and efficacy, as available. Dose-escalation part of this study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 9 patients each within each cohort in an open-label fashion. Patients who meet eligibility criteria will be enrolled in the dose-escalation part, receiving WSK-IM02 as monotherapy via intraperitoneal injection twice weekly on Days 1, 5, 8, and 12 of repeated 14-day cycles in escalating doses. Patients will only receive WSK-IM02 for one cycle during the 28-day DLTs observation period. If a patient shows no disease progression or intolerable toxicity after completing DLTs observation, the investigator will discuss with the patient whether to continue subsequent treatment. If treatment is continued, the patient enters the treatment period. Enrollment for the next Dose Level can only begin once all patients at a given Dose Level have completed DLTs observation and have not met the termination criteria for dose escalation, and the safety has been evaluated and declared to be safe by the Safety Review Committee (SRC). After determination of Maximum Tolerated Dose (MTD) or Maximum Administrated Dose (MAD) and the expected effective Dose Level, the next part with expansion cohorts will commence to further evaluate the RP2D.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: