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Sacituzumab Tirumotecan Plus Immunotherapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT07686588 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-07

No results posted yet for this study

Summary

This is a single-center, open-label phase 2 study evaluating sacituzumab tirumotecan in combination with an immune checkpoint inhibitor in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma.

Eligible patients will have recurrent or metastatic head and neck squamous cell carcinoma that has progressed after prior standard therapy including an immune checkpoint inhibitor. Sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, will be administered by intravenous infusion every 2 weeks in combination with the patient's ongoing immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.

The primary endpoint is objective response rate (ORR), as assessed by the investigator according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety and tolerability.

Conditions

  • Recurrent or Metastatic Head and Neck Carcinoma

Interventions

DRUG

Sacituzumab Tirumotecan Plus Immune Checkpoint Inhibitor

Participants will receive sacituzumab tirumotecan 5 mg/kg by intravenous infusion once every 2 weeks in combination with an immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.

Sponsors & Collaborators

  • Biying Chen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686588 on ClinicalTrials.gov