NCT07136545View on ClinicalTrials.gov

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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
HNSCC
Interventions
DRUG

HCB101

QW

DRUG

Pembrolizumab

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

Trial Locations (3)

100

RECRUITING

National Taiwan University Hospital, Taipei

112

RECRUITING

Taipei Veterans General Hospital, Taipei

333

RECRUITING

Chang-Gung Memorial Hospital(Lin-Kou), Taoyuan District

Sponsors

Collaborators (1)

FBD Biologics Limited
All Listed Sponsors
collaborator

FBD Biologics Limited

INDUSTRY

collaborator

National Taiwan University Hospital

OTHER

collaborator

Chang Gung Memorial Hospital

OTHER

lead

Taipei Veterans General Hospital, Taiwan

OTHER_GOV