A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)

Официальное название

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer

Обзор

This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Liposomal doxorubicin, Paclitaxel or Topotecan
  Administration by intravenous infusion for a cycle of 4 weeks.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Overall survival (OS) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (8)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Time to Response (TTR) [Срок оценки: Up to approximately 24 months]
• RR (Response Rate) [Срок оценки: Up to approximately 24 months]
• CA-125 Response Rate [Срок оценки: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age: ≥18 years old;
• Expected survival time ≥3 months;
• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
• Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;
• Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;
• For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Критерии исключения

• Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;
• Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;
• Front line received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Diagnosed with active malignancy within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs;
• Patients with poor glycemic control;
• Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system metastases;
• Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
• Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
• Had a history of autologous or allogeneic stem cell transplantation;
• Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
• A history of severe neurological or psychiatric illness;
• Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
• Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;
• Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06994195 · BL-B01D1-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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