A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

NCT06006169 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-SI-B003-201-03
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  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.

  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, SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

Drug: BL-B01D1; Drug: SI-B003

Interventions

BL-B01D1 DRUG

BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.

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

Study treatment

SI-B003 DRUG

SI-B003 was administered intravenously every 3 weeks (Q3W).

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:

• All subjects voluntarily participated in the study and signed informed consent.
• Male or female aged ≥18 years and ≤75 years.
• Expected survival time ≥3 months.
• ECOG 0-1.
• Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) confirmed by histopathology and/or cytology:
• Cohort\_A, B, and Cohort\_C Stage I patients who had failed or were intolerant to 1 or more lines of systemic therapy for recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma);
• Cohort\_C Stage II patients who had not received any previous systemic antitumor therapy (other than induction chemotherapy, neoadjuvant, or adjuvant therapy) for recurrent or metastatic HNSCC (non-nasopharyngeal); Treatment failure was defined as disease progression during or after systemic antitumor therapy.
• Intolerance refers to the refusal of patients to continue the original regimen due to grade 3-4 adverse reactions after receiving standard treatment.
• Note: Recurrence or disease progression within 6 months after the last chemotherapy of multimodal therapy was considered as the first line of treatment.

You may not qualify if:

• Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions that had been previously treated with radiation could be included in a measurable lesion only if there was definite disease progression after radiation therapy.
• No blood transfusions and no use of cell growth factors and/or platelet-raising drugs during the 14 days prior to the screening period must be allowed, and the organ function level must meet the following criteria:
• Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;
• Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
• Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present;
• coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;
• no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;
• proteinuria ≤2+ or ≤1000mg/24h.
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities such as ALP elevation, hyperuricemia, and hyperglycemia, as judged by the investigator, and toxicity without safety risk, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin ≥90g/L, as judged by the investigator).
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, the 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 whole treatment cycle and for 6 months after the end of treatment.
• Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin.
• Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose.
• Non-squamous cell tissue confirmed by histopathology and/or cytology must be excluded.
• Cohort\_C Stage II patients who had received any previous systemic therapy for recurrent or metastatic HNSCC (other than induction chemotherapy, adjuvant or neoadjuvant therapy) were excluded.
• Cohort\_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis, excluded.

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 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

Study Officials

• Chaosu Hu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Dongmei Ji

  Fudan University

  PRINCIPAL INVESTIGATOR

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 17, 2023
• First Posted: August 23, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CN (1)