A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Korábbi kezelés

• Participation in another investigational drug trial within 4 weeks before enrollment.
• 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.
• 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).
• Known history of drug/alcohol/substance abuse, definite prior history of neurological or psychiatric disorders.
• Corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 4 weeks prior to study drug, or requiring long-term systemic steroids during study (topical steroids allowed).
• Uncontrolled or significant cardiovascular disease, including severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction within 6 months prior to the first dose.
• Known allergy to the investigational product or its major excipients, or kanamycin.
• History of thromboembolism, cerebral infarction, hemorrhagic disorders, or evidence of bleeding tendency within 6 months prior to the first dose.
• Any other concurrent severe and/or uncontrolled medical condition that, in the investigator's judgment, renders the patient unsuitable for participation.

Más betegség

• Non-epithelial ovarian cancer.
• Active infection requiring systemic anti-infective therapy (per investigator).
• Presence of any active autoimmune disease, history of autoimmune disease or acquired immunodeficiency syndrome.
• Poorly controlled hypertension despite antihypertensive therapy (i.e., SBP ≥150 mmHg and/or DBP ≥100 mmHg).
• Pulmonary disease defined as ≥ Grade 3 per NCI-CTCAE v6.0, including dyspnea at rest, requirement for continuous oxygen therapy, or history of ILD.
• Abdominal adhesions or infection precluding intraperitoneal drug administration.
• Physical condition unsuitable for intraperitoneal injection or other factors precluding study completion per investigator.

Laborértékek

• HIV positive, HbsAg positive with HBV DNA > ULN (enrollment allowed if reduced to normal post-antiviral), Anti-HCV positive with HCV RNA positive, Tp-Ab positive.
• Uncontrolled diabetes (defined as HbA1c ≥8%, or 7% ≤ HbA1c <8% with clinical symptoms of diabetes, such as polyuria, polydipsia, polyphagia, and weight loss) or other metabolic disorders, severe gastrointestinal bleeding, severe diarrhea (CTCAE ≥ Grade 2), or severe gastrointestinal obstruction requiring intervention.

Életkor

• 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).

Egyéb

• Symptomatic CNS or leptomeningeal metastases, or other evidence of uncontrolled CNS or leptomeningeal metastases, and deemed inappropriate for enrollment by investigator.
• Pregnant or breastfeeding.
• Female patients of childbearing potential unwilling to use effective contraception during the trial and for 6 months post-treatment. Pregnancy test required for patients with amenorrhea on antineoplastics, even if >12 months.
• Intestinal stoma or obstruction.

• 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.
• Female subjects of childbearing potential must agree to use effective contraceptive methods from signing ICF until at least 6 months after the last dose of the investigational product.