A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

NCT07232524 | Recruiting Phase 1

• 1 other identifier: BL-M24D1-104
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors.

Conditions

Head and Neck Squamous Cell Carcinoma; Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Phase Ia: Dose limiting toxicity (DLT)

  DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

  Up to 28 days after the first dose

• Phase Ia: Maximum tolerated dose (MTD)

  MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

  Up to 28 days after the first dose

• Phase Ib: 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-M24D1.

  Up to approximately 24 months

Secondary Outcomes (11)

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

• T1/2

  Up to approximately 24 months

• AUC0-t

  Up to approximately 24 months

Study Arms (1)

BL-M24D1

EXPERIMENTAL

Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 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-M24D1

Interventions

BL-M24D1 DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

BL-M24D1

Eligibility Criteria

• Age: 18 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 comply with the protocol requirements;
• Gender unrestricted;
• Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
• Expected survival time ≥3 months;
• Patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic foci within the past 3 years;
• Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
• ECOG performance status score of 0 or 1;
• Toxicities from prior antitumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000mg/24h;
• For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative. Patients must not be lactating. All enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after treatment ends.

You may not qualify if:

• Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives prior to the first dose;
• History of severe heart disease;
• QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
• Active autoimmune or inflammatory diseases;
• Diagnosis of other malignancies within 5 years prior to the first dose;
• Hypertension poorly controlled by two antihypertensive medications;
• Poorly controlled blood glucose levels;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Lung diseases graded ≥3 according to CTCAE v5.0;
• Symptoms of active central nervous system metastasis;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Cumulative anthracycline dose \>360 mg/m² during prior (neo)adjuvant anthracycline therapy;
• Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• History of interstitial lung disease (ILD) requiring steroid treatment, or current ILD;

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

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

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)