OncoMatch/Clinical Trials/NCT06769152
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
Is NCT06769152 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX43 DOSE 1 and HLX43 DOSE 2 for cervical cancer.
Treatment: HLX43 DOSE 1 · HLX43 DOSE 2 · HLX43 DOSE 3 — The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Ovarian Cancer
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period
Disease stage
Required: Stage IV
Metastatic disease required
Metastatic or recurrent cervical cancer... Cohort 2: Histologically confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard systemic therapy — cervical cancer
Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive [CPS≥1], the standard therapy is defined as platinum-based chemotherapy in combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative [CPS<1], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy
Must have received: platinum-based chemotherapy — ovarian cancer
Ovarian cancer patients with platinum-resistant disease: ... platinum resistance is defined as having received at least 4 cycles of platinum-based chemotherapy, with the tumor showing a response to platinum-based chemotherapy (best tumor assessment being complete remission/partial remission), and the time from the last platinum-based chemotherapy to tumor progression being >3 months and ≤6 months. If the patient has previously received multiple lines of platinum-based chemotherapy, platinum resistance is defined as disease progression occurring during the last line of platinum-based chemotherapy treatment or within 6 months after the last platinum-based chemotherapy.
Cannot have received: ADC drugs with topoisomerase I inhibitors as toxins
Previously received ADC drugs with topoisomerase I inhibitors as toxins
Lab requirements
Blood counts
Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)
Kidney function
Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)
Liver function
Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)
Cardiac function
Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg despite active treatment)
Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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