A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

NCT05668858 | Recruiting Phase 1

• 1 other identifier: SI-B001-SI-B003-201
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK/PD, immunogenicity were evaluated.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (5)

• 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 SI-B001+SI-B003.

  Up to approximately 24 months

• Phase Ib: 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

• Phase Ib: Dose Limited Toxicity (DLT)

  The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

  Up to approximately 24 months

• Phase Ib: Maximum Tolerated dose (MTD) or maximum administered dose (MAD)

  In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

  Up to approximately 24 months

• Phase II: 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 (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Phase Ib/II: Disease control rate (DCR)

  Up to approximately 24 months

• Phase Ib/II: Duration of response (DOR)

  Up to approximately 24 months

• Phase Ib/II: Progression-free survival (PFS)

  Up to approximately 24 months

• Phase Ib/II: Cmax

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants will receive treatment during the first cycle. Participants with clinical benefits received more cycles of additional therapy. Administration will be discontinued due to disease progression or occurrence of intolerable toxicity or other reasons.

Drug: SI-B001; Drug: SI-B003

Interventions

SI-B001 DRUG

Administration by intravenous infusion

Study treatment

SI-B003 DRUG

Administration by intravenous infusion

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:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Histologically or cytologically confirmed head and neck squamous cell carcinoma occurring only in the oral cavity, oropharynx, hypopharynx, and larynx;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Performance status score: ECOG ≤1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤1+ or ≤1000 mg/24h;
• Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.

You may not qualify if:

• Squamous cell carcinoma originating from the nasopharynx, salivary glands, nasal sinuses, skin, or with an unknown primary site;
• For Phase II patients, either: a) those suitable for and willing to undergo local therapy; or b) those who have received systemic chemotherapy, excluding chemotherapy administered as part of multimodal treatment for locally advanced disease;
• Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases) and/or spinal cord compression;
• Participation in any other clinical trial within 4 weeks prior to the administration of this trial's investigational product (based on the last dose date);
• Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first dose of the study drug;
• Major surgery (as defined by the investigator) within 4 weeks prior to the first dose;
• Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before the study drug administration;
• Pulmonary diseases graded as ≥Grade 3 according to NCI-CTCAE v5.0; current or history of interstitial lung disease (ILD);
• Active infection requiring intravenous anti-infective therapy;
• Prior immunotherapy leading to ≥Grade 3 immune-related adverse events (irAE) or ≥Grade 2 immune-related myocarditis;
• Use of live attenuated vaccines within 4 weeks before the first dose of the study drug;
• Use of immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of the study drug;
• Patients at risk of active autoimmune diseases or with a history of autoimmune diseases;
• History of other malignancies within 5 years before the first dose;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200000, 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

• Ye Guo, PHD

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; 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: December 9, 2022
• First Posted: December 30, 2022
• Study Start: February 10, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)