New drug cocktail shows promise for tough liver cancer
NCT ID NCT06986785
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called BL-B01D1, alone or with other cancer drugs, in 74 people with advanced liver cancer that has spread. The goal is to see if these combinations can shrink tumors and how safe they are. Participants will receive the drugs through an IV or as pills over several weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-B01D1 (a drug that targets cancer cells) combined with lenvatinib, finotonlimab (a PD-1 inhibitor), and/or bevacizumab
- What this could lead to
- If successful, this could provide new treatment options for people with advanced liver cancer that has not responded to other therapies.
- What could go wrong
- This is an early Phase 2 trial with only 74 participants, so results may not apply to everyone. The drug combinations may cause side effects and may not shrink tumors or extend life.
Why investors are watching
Sichuan Baili is testing its drug BL-B01D1, alone and in combinations, against advanced liver cancer in a 74-patient phase II study. For a small company, this readout tests whether BL-B01D1 works in a common cancer and whether combining it with other drugs improves results. A clear signal could define the drug's future path, while a weak one would leave the company without a key data point.
If it works: A positive result could show BL-B01D1 has activity in liver cancer, supporting further development and possible partnerships. It could also clarify which combination, if any, works best, giving the company a clearer direction.
If it fails: The trial could fail to show meaningful disease control, or the combinations could prove too toxic. Trials at this stage often miss their goals, and a negative readout would likely set the program back and reduce investor confidence.
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 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
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. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Gender is not limited; 3. Age ≥18 years old and ≤75 years old; 4. Expected survival time ≥3 months; 5. Patients with advanced HCC confirmed by histology or cytology; 6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG score was 0-1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. Organ function level must meet the requirements; 12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN; 13. Urinary protein ≤2+ or ≤1000mg/24h; 14. No cirrhosis or only Child-Pugh A cirrhosis; 15. If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test; 16. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, a 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. Patients with active central nervous system metastases; 2. Who had participated in any other clinical trial within 4 weeks before the trial dose; 3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug; 4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose; 5. Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing; 6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment; 7. Serious systemic infection within 4 weeks before screening; 8. Patients at risk for active autoimmune disease or with a history of autoimmune disease; 9. Other malignant tumors within 5 years before the first treatment; 10. Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection; 11. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms; 12. Diabetic patients with poor glycemic control; 13. Had a history of severe cardiovascular and cerebrovascular diseases; 14. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation; 15. Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened; 16. Patients with massive or symptomatic effusions or poorly controlled effusions; 17. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart; 18. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 19. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin; 20. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug; 21. The cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy; 22. Pregnant or lactating women; 23. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 24. Other conditions for trial participation were not considered appropriate by the investigator.
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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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Zhongshan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Immunotherapy drug durvalumab may be safe for liver cancer patients with active hepatitis b
- Immunotherapy-Targeted therapy combo shows promise for advanced liver cancer
- New drug zanzalintinib tested for advanced liver cancer
- Promising drug cocktail targets Hard-to-Treat liver cancer
- Virus therapy takes on liver cancer in major trial