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.
Female, age ≥18 years old, ≤ 75 years old.
Willing to voluntarily sign the informed consent form.
Patients must have histopathologically confirmed ovarian cancer, with no requirement for additional tumor tissue biopsy during the screening period.
Platinum-resistant recurrent ovarian cancer, with an initial response to ≥4 cycles of platinum-based therapy, followed by confirmed disease recurrence or progression 28 days to 6 months after the last platinum-containing regimen. At least one subsequent systemic therapy for recurrence/progression following platinum resistance, with ≤3 prior lines of systemic therapy (neoadjuvant + adjuvant chemotherapy/adjuvant chemotherapy counts as one chemotherapy line. Other maintenance therapies may be excluded upon investigator and sponsor 's agreement.
Participation in another investigational drug trial within 4 weeks before enrollment.
Non-epithelial ovarian cancer.
Prior antineoplastic therapy (including chemotherapy, radiotherapy, targeted therapy, hormonal therapy, biologic therapy, immunotherapy, herbal medicine for antineoplastic purposes, or other investigational agents) within 28 days or 5 half-lives (whichever shorter) prior to first dose.
Prior radiotherapy within 4 weeks prior to the first dose (including radiotherapy to >25% of bone marrow), or palliative localized radiotherapy to bone metastases within 2 weeks.
Sequential
WSK-IM02
Drug3.33 μg/kg, 8.33 μg/kg, or 16.67 μg/kg of WSK-IM02 as monotherapy via intraperitoneal injection.
WSK-IM02
DrugExpected effective dose level of of WSK-IM02 as monotherapy via intraperitoneal injection.
Dose-escalation part: Observation of DLT
DLT is defined as any clinically significant adverse event or abnormal laboratory value that is reasonably related to the investigational drug (probably, very likely, or definitely related) as defined in the protocol occurring during the 28-day DLTs observation period (Days 1-28) of Dose-escalation part. Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Dose-escalation part: Determination of the MTD or MAD
The maximum tolerated dose (MTD) is defined as the highest dose level below the maximum administered dose (MAD) that has confirmed 2 or more participants with DLT. At least 6 participants have blood samples that evaluable for the PK endpoints must be enrolled at this dose level before it may be confirmed as the MTD.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
