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Head and Neck Squamous Cell CarcinomasPhase 2NCT07788950

A Study of BL-M08D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

A Phase 2 study testing BL-M08D1 in people with Head and Neck Squamous Cell Carcinomas and Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This Phase II study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic squamous cell carcinoma of the head and neck and other solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-M08D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Sep 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form and agree to comply with the requirements of the protocol;
  • No gender restriction;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) and other solid tumors;
  • Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions obtained within 3 years;
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  • Must have at least one measurable lesion as defined by RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;
  • Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  • No severe cardiac dysfunction; left ventricular ejection fraction (LVEF) ≥50%;
  • Organ function levels must meet the protocol-specified requirements;
  • Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
  • Urine protein ≤1+ or ≤1000 mg/24h;
  • For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and must be non-lactating; all trial participants (both male and female) must agree to use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;
  • Participants must be capable of and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures as required by the protocol.

Who cannot join

  • Received chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
  • History of severe cardiac or cerebrovascular disease;
  • Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
  • Active autoimmune diseases and inflammatory diseases;
  • Diagnosed with another malignant tumor within 5 years prior to the first dose;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
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  • Hypertension poorly controlled by antihypertensive medication;
  • Poorly controlled blood glucose;
  • History of interstitial lung disease (ILD) requiring corticosteroid therapy, or currently diagnosed with ILD, or grade ≥2 radiation pneumonitis;
  • Severe impairment of respiratory function;
  • Active central nervous system (CNS) metastases;
  • Prior or concurrent central nervous system lesions;
  • Participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;
  • Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
  • Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
  • Active infections requiring systemic therapy within 4 weeks prior to the first dose of study drug;
  • Pleural, peritoneal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of study drug;
  • Imaging findings suggest tumor invasion or encasement of abdominal, thoracic, or other major vessels;
  • Received another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
  • Pregnant or breastfeeding women;
  • Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Dongmei Ji

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

This Phase II study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic squamous cell carcinoma of the head and neck and other solid tumors.

Being tested
BL-M08D1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M08D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT07788950
Study groupRoleWhat they receive
BL-M08D1ExperimentalParticipants receive BL-M08D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: BL-M08D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M08D1.

    Measured: Up to approximately 24 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

Secondary outcomes (11)

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  4. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.

    Measured: Up to approximately 24 months

  5. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Measured: Up to approximately 24 months

  6. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Measured: Up to approximately 24 months

  7. T1/2

    T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.

    Measured: Up to approximately 24 months

  8. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Measured: Up to approximately 24 months

  9. CL (Clearance)

    Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.

    Measured: Up to approximately 24 months

  10. Ctrough

    Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  11. Anti-drug Antibody (ADA)

    Frequency of anti-BL-M08D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07788950
Sponsor's protocol ID
BL-M08D1-204
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-M08D1 in people with Head and Neck Squamous Cell Carcinomas and Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07788950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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