OncoMatch/Clinical Trials/NCT07063212
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Is NCT07063212 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Cetuximab for squamous cell carcinoma of head and neck.
Treatment: Sacituzumab Govitecan · Cetuximab — The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and/or metastatic head and neck squamous cell cancer (HNSCC).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy — first line
Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial
Cannot have received: topoisomerase I inhibitor
Patients who have previously received topoisomerase I inhibitors for HNSCC
Cannot have received: EGFR antibody based therapy
Exception: previous severe infusion or allergic reactions deemed unsafe for re-challenge
Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge
Cannot have received: anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy
Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 9.0 g/dl (transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
Kidney function
Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 30 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. AST and ALT < 2.5 x ULN. Albumin ≥ 3 g/dL
Adequate hematologic function within 30 days prior to registration, defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 9.0 g/dl; Adequate renal function within 30 days prior to registration, defined as follows: Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 30 ml/min; Adequate hepatic function within 30 days prior to registration, defined as follows: Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. AST and ALT < 2.5 x ULN. Albumin ≥ 3 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07063212 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase I inhibitor, EGFR antibody based therapy, anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages