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Compares treatment options for Epithelial Ovarian Cancer
Official title A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)
ClinicalTrials.gov ID: NCT06994195
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epithelial ovarian cancer.
Also referred to as iza-bren, izalontamab brengitecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative...
- 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;
See the full eligibility criteria
- 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 people 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...
- 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;
- people 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.