Can a drug duo tame Triple-Negative breast cancer?
NCT ID NCT06471205
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining BL-B01D1, a targeted drug, with a PD-1 monoclonal antibody can shrink tumors in people with advanced triple-negative breast cancer that cannot be surgically removed or has spread. The study enrolls about 52 adults aged 18 to 75 who have not had prior systemic therapy for their advanced disease. Researchers are measuring how many patients respond to the treatment and how long the benefit lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of BL-B01D1 (izalontamab brengitecan) and a PD-1 monoclonal antibody
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced triple-negative breast cancer, a disease with limited therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. Combination therapies can also increase the risk of side effects.
Why investors are watching
Sichuan Baili Pharmaceutical is running a phase II trial of its drug BL-B01D1 combined with a PD-1 antibody in patients with advanced triple-negative breast cancer, a hard-to-treat disease. For a small company, this readout tests whether its combination can control the disease in a meaningful way, and the result will shape the drug's future value.
If it works: A positive result could show the combination shrinks or stabilizes tumors, giving the company a stronger case to move the drug into later-stage testing or seek partnerships. That would validate the drug's potential in a tough cancer type.
If it fails: The trial could fail to show enough benefit, or the combination could prove too toxic, which would set the program back. Trials in advanced cancer often fail, so a negative result is a real possibility for a company of this size.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. Age: ≥18 years old and ≤75 years old; 3. Expected survival time ≥3 months; 4. ECOG 0 or 1; 5. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer; 6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer; 7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided; 8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions; 9. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins; 2. Palliative radiotherapy within 2 weeks before the first dose; 3. Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy; 4. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Active autoimmune and inflammatory diseases; 8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose; 9. Other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. 6 months prior to screening needs treatment intervention unstable thrombotic events; 14. Patients with active central nervous system metastases; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. Participated in another clinical trial within 4 weeks before the first dose; 21. Patients with superior vena cava syndrome should not be rehydrated; 22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
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- Can a new tracer make tumors light up on scans?
- Can a platform trial match the right drug combo to each tumor?