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

NCT07788950 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-M08D1-204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinomas; Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 24 months

• 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.

  Up to approximately 24 months

Secondary Outcomes (11)

• Progression-free Survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-M08D1

EXPERIMENTAL

Participants 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.

Drug: BL-M08D1

Interventions

BL-M08D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M08D1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (1)