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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer (NCT06994195) is a Phase 3 interventional studying Epithelial Ovarian Cancer and Fallopian Tube Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Epithelial Ovarian Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 384 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily sign the willing to sign a consent form form and comply with the protocol requirements; 2. Age: ≥18 years old; 3. Expected survival time ≥3 months; 4. diagnosed by tissue sample (biopsy-confirmed) epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 5. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence; 6. 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; 7. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine; 8. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years; 9. Must have at least one measurable lesion as defined by RECIST v1.1; 10. ECOG performance status score of 0 or 1; 11. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 12. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 13. Organ function levels must meet the requirements; 14. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN; 15. 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. Who Should NOT Join This Trial: 1. 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age: ≥18 years old; 3. Expected survival time ≥3 months; 4. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 5. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence; 6. 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; 7. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine; 8. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years; 9. Must have at least one measurable lesion as defined by RECIST v1.1; 10. ECOG performance status score of 0 or 1; 11. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 12. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 13. Organ function levels must meet the requirements; 14. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN; 15. 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. Exclusion Criteria: 1. 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; 2. Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy; 3. Front line received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3; 4. History of severe heart disease and cerebrovascular disease; 5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 6. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Diagnosed with active malignancy within 3 years before randomization; 8. Hypertension poorly controlled by two antihypertensive drugs; 9. Patients with poor glycemic control; 10. Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD; 11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 12. Patients with active central nervous system metastases; 13. Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 14. Patients with massive or symptomatic effusions or poorly controlled effusions; 15. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 16. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent; 17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 18. Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea; 19. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1; 20. Had a history of autologous or allogeneic stem cell transplantation; 21. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; 22. A history of severe neurological or psychiatric illness; 23. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization; 24. Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization; 25. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.

Treatments Being Tested

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Liposomal doxorubicin, Paclitaxel or Topotecan

Administration by intravenous infusion for a cycle of 4 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06994195), the sponsor (Sichuan Baili Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06994195 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06994195?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06994195?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06994195. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06994195. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.