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.