A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)

NCT07136545 | Recruiting Phase 1 DMC

• 1 other identifier: 2025-01-015B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a non-randomized, open-label, dose-escalation and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II). Subjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with pembrolizumab (200 mg IV day 1; given every 21 days) until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (2)

• Number of subjects with MTD of HCB101 in combination with pembrolizumab

  To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab

  2 Years

• Overall Rate Response (ORR)

  To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab

  2 Years

Secondary Outcomes (3)

• Number/incidence and percentage of subjects with AEs, SAEs, and TEAEs

  2 Years

• Progression-Free Survival (PFS)

  2 Years

• Quality of life (EORTC QLQ-H&N35) change

  2 Years

Study Arms (1)

HCB101+Pembrolizumab

EXPERIMENTAL

Drug: HCB101; Drug: Pembrolizumab

Interventions

HCB101 DRUG

QW

HCB101+Pembrolizumab

Pembrolizumab DRUG

200 mg IV on Day 1, cycled every 21 days;

HCB101+Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• \. Subjects are able to understand and willing to provide signed informed consent as described in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.
• \. Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.
• \. With histologically/cytologically confirmed diagnosis of HNSCC
• \. With progression after 1st cisplatin based therapy for R/M HNSCC or within 6 months after cisplatin based CCRT
• \. Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• \. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Screening.
• \. Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).
• \. Have adequate organ function, as indicated by the following laboratory parameters in below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days prior to the administration of the first dose of study intervention).
• a) Absolute neutrophil count ≥1.5 × 109/L
• b) Platelets ≥75 × 109/L
• c) Hemoglobin ≥9.5 g/dL
• d) Total bilirubin ≤1.5 × upper limit of normal (ULN), \<3.0 × ULN if known Gilbert's disease
• e) Alanine aminotransferase and aspartate aminotransferase ≤3× ULN and ≤5× ULN for subject with liver metastasis
• f) Creatinine clearance ≥50 mL/min (using Cockcroft Gault equation)
• g) Coagulation: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5× ULN (The INR applies only to subjects who do not receive therapeutic anticoagulation). For subjects receiving therapeutic anticoagulation, the INR should be within the therapeutic range for the intended use of the anticoagulants.)

You may not qualify if:

• \. Medical Conditions:
• a) With a known history of hypersensitivity to any components of the study intervention.
• b) Subjects who have other malignancies requiring treatment within 2 years prior to the first dose of study intervention will be excluded, except for radically treated locally curable basal or squamous cell skin cancer and other malignancies that have been treated with no relapse within 2 years.
• c) Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study intervention. Subjects on low-dose corticosteroids (\<20 mg prednisolone or equivalent per day) may participate.
• d) Clinically significant cardiovascular condition, including 1)History of congestive heart failure (New York Heart Association Class \>2), with only heart failure with preserved ejection fraction (HFpEF) included; 2)History of unstable angina within 6 months prior to the first dose of study intervention; 3)New-onset angina or myocardial infarction within 6 months prior to the first dose of study intervention; 4)New-onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months prior to the first dose of study intervention and still in unstable condition and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed, provided the condition is stably controlled.
• e) History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart rate using Fridericia's correction \[QTcF\] \>470 msec at Screening, pacemaker installation, or previous diagnosis of congenital long QT syndrome).
• f) Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia (Note: subjects with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the Investigator, Grade 2 chemotherapy-induced neuropathy.)
• g) With known inherited or acquired bleeding disorders or bleeding diathesis.
• h) With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
• i) With active autoimmune diseases that required systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past two years are excluded. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is allowed.
• j) With a history of or current non-infectious pneumonitis.
• k) With a history of severe hypersensitivity to monoclonal antibodies.
• \. Prior/Concomitant Therapy/Treatment
• a) Subjects who have undergone major surgery or radical radiotherapy within 28 days prior to the first dose of study intervention.
• b) Subjects who have undergone any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal/alternative therapies with anti-cancer indications or targeted therapy) within 14 days or 5 half lives, whichever is longer, prior to the first dose of the study intervention.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• FBD Biologics Limited: collaborator
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (3)

Chang-Gung Memorial Hospital(Lin-Kou)

Taoyuan District, Guishan District, 333, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taipei city, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, taipei city, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

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

• Mu-Hsin Chang

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris chang

CONTACT

+886-2-2871-2121; iris.c8987223@protonmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

TW (3)