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)

Not Applicable

Recruiting

• Conditions: HNSCC
• Interventions: Drug: HCB101; Drug: Pembrolizumab

• Registration Number: NCT07136545
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCB101+Pembrolizumab	HCB101	-
HCB101+Pembrolizumab	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with MTD of HCB101 in combination with pembrolizumab	2 Years	To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab
Overall Rate Response (ORR)	2 Years	To evaluate the safety and efficacy of HCB101 in combination with pembrolizumab

Secondary Outcome Measures

Name	Time	Method
Number/incidence and percentage of subjects with AEs, SAEs, and TEAEs	2 Years	To characterize the safety profiles of HCB101 in combination with pembrolizumab.
Progression-Free Survival (PFS)	2 Years	To evaluate the anti-tumor activity of HCB101 in combination with pembrolizumab.
Quality of life (EORTC QLQ-H&N35) change	2 Years	To evaluate the quality of life (QOL) change after treatment of HCB101 in combination with pembrolizumab

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taipei City, Taiwan