New drug combo aims to shrink Hard-to-Treat lung and throat cancers
NCT ID NCT05956587
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests two drugs, SI-B003 and BL-B01D1, alone or together in 121 adults with advanced non-small cell lung cancer or nasopharyngeal carcinoma. The goal is to see if the combination shrinks tumors and to find the safest, most effective dose. Participants must have tried other treatments and have a life expectancy of at least 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SI-B003 and BL-B01D1 (izalontamab brengitecan) given by IV
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced lung or nasopharyngeal cancers that have not responded to other therapies.
- What could go wrong
- This is an early phase II trial with only 121 participants, so results may not apply to everyone. The combination may cause side effects or fail to shrink tumors.
Why investors are watching
Sichuan Baili Pharmaceutical is running a phase II trial of its drug BL-B01D1 combined with SI-B003 in patients with advanced lung cancer, nasopharyngeal cancer, and other solid tumors. For a small company, this readout tests whether its combination therapy can control disease in hard-to-treat cancers, which would validate its pipeline and support further development.
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 trials. That could raise the drug's commercial value and attract partnership interest.
If it fails: The trial could fail to show enough benefit or produce safety problems, which would set the program back. Trials in advanced cancers often fail, and a negative readout could hurt the company's prospects and delay any potential approval.
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 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- 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 histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma; 6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 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. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN; 13. Urinary protein ≤2+ or ≤1000mg/24h; 14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. For stage 3 Cohort\_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent; 2. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil; 3. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis; 4. Use of immunomodulatory drugs within 14 days before the first dose of study drug; 5. History of severe heart disease; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block; 7. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing; 8. Active autoimmune and inflammatory diseases; 9. Other malignancies diagnosed within 5 years before the first dose; 10. Hypertension poorly controlled by two antihypertensive drugs; 11. Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with current or history of ILD; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 13. Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent; 14. Patients with active central nervous system metastases; 15. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug; 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection; 18. Active infection requiring systemic therapy; 19. Had participated in another clinical trial within 4 weeks before the first dose; 20. The investigator did not consider it appropriate to use other conditions 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
16 sites. 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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Chongqing University Cancer Hospital
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, China
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Hunan Cancer Hospita
NOT_YET_RECRUITINGChangsha, Hunan, China
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Linyi Cancer Hospital
RECRUITINGLinyi, Shangdong, China
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Liuzhou People's Hospital
NOT_YET_RECRUITINGLiuzhou, Guangxi, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510000, China
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The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITINGLuoyang, Henan, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITINGXi’an, Shanxi, China
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The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The Second Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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Tianjin Medical University General Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Union Hospital Tongji Medical College， Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?