A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinu… (NCT07462468) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
36 participantsStarted 2026-03-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. ECOG performance status: 0 - 2.
✓. Life expectancy ≥3 months.
✓. Adequate major organ function within 14 days prior to treatment : Hematology (without transfusion or hematopoietic growth factor support within 14 days): NEUT ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥80 g/L. Liver function: ALT ≤2.5 × ULN, AST ≤2.5 × ULN. In the presence of liver metastases, ALT and AST ≤5 × ULN. Renal function: Cr ≤1.5 × ULN or Ccr \>50 mL/min. Coagulation function: APTT ≤1.5 × ULN, INR ≤1.5 × ULN.
✓. At least one measurable lesion per RECIST v1.1 criteria.
Exclusion criteria
✕. Participation in another investigational drug trial within 4 weeks before enrollment.
What they're measuring
1
Dose-escalation part: Observation of DLT
Timeframe: 4 weeks
2
Dose-escalation part: Determination of the MTD or MAD
✕. 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.
✕. Major surgery within 4 weeks prior to the first dose without complete recovery, or elective surgery planned during the trial.
✕. Other malignancies within the past 5 years (except stable breast cancer; except for adequately treated non-melanoma skin cancer or other solid tumors with no evidence of disease for \>5 years).
✕. Any toxicity from prior therapy that has not recovered to baseline or to ≤ Grade 1 per NCI-CTCAE v6.0 prior to study treatment (except those posing no safety risk per investigator, e.g., alopecia).
✕. Symptomatic CNS or leptomeningeal metastases, or other evidence of uncontrolled CNS or leptomeningeal metastases, and deemed inappropriate for enrollment by investigator.