A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

NCT06437522 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-204-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

  Up to approximately 24 months

• 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-B01D1.

  Up to approximately 24 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion 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-B01D1; Drug: PD-1 monoclonal antibody

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

Study treatment

PD-1 monoclonal antibody DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Study treatment

Eligibility Criteria

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

You may qualify if:

• Subject volunteered to participate in the study and signed an informed consent;
• Male or female aged ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• ECOG score 0-1;
• Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology;
• Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation 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.

You may not qualify if:

• Prior treatment with an ADC drug with TOP I inhibitors as a toxin;
• Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose;
• Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma;
• Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
• Use of an immunomodulatory drug within 14 days before the first dose of study drug;
• Systemic corticosteroids were required within 2 weeks before the first dose of the study;
• Has a history of severe disease of heart head blood-vessel;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors that progressed or required treatment within 3 years before the first dose;
• With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;
• Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with active central nervous system metastasis;
• Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage;
• Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;

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

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Chaosu Hu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Dongmei Ji

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; 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: May 27, 2024
• First Posted: May 31, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)