Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Becotatug Vedotin: Becotatug vedotin as one of the drugs used in neoadjuvant therapy.
Pucotenlimab: Pucotenlimab as one of the drugs used in neoadjuvant therapy.
Study summary
This is a prospective, single-arm, multi-center, Phase II clinical trial evaluating the efficacy and safety of neoadjuvant becotatug vedotin (an anti-EGFR antibody-drug conjugate) combined with pucotenlimab (HX008, an anti-PD-1 monoclonal antibody) in patients with resectable recurrent head and neck squamous cell carcinoma (rHNSCC) who have progressed on prior PD-1/PD-L1 inhibitor and platinum-based therapy.
A total of 42 EGFR-positive patients will be enrolled using Simon's two-stage design across 11 centers in China (Stage 1: 25 patients; Stage 2: 17 additional patients with 5% dropout). Enrolled patients will receive 3 cycles of neoadjuvant becotatug vedotin (2.3 mg/kg, IV, Q3W) plus pucotenlimab (3 mg/kg, IV, Q3W), followed by salvage surgery (3-4 weeks later), adjuvant radiotherapy +/- chemotherapy per NCCN/CSCO guidelines, and pucotenlimab maintenance therapy (3 mg/kg, Q3W) for up to 12 cycles or until disease progression or unacceptable toxicity.
The primary endpoint is major pathological response (MPR) rate. The null hypothesis MPR rate is 14% (historical data) and the target MPR rate is 30% (alpha=0.05, power=0.8, one-sided). Secondary endpoints include objective response rate (ORR), pathological complete response (pCR), survival outcomes, quality of life, and safety.
Eligibility
Primary outcome measure(s)
- Major Pathological Response Rate (MPR) — At time of surgery, approximately 12 weeks after enrollment
Proportion of patients with less than or equal to 10% viable tumor cells in the surgically resected specimen after neoadjuvant therapy, assessed by central pathology review.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| The First People's Hospital of Foshan | Foshan | Guangdong | |
| Cancer Hospital of Guangzhou Medical University | Guangzhou | Guangdong | |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | |
| Qingyuan People's Hospital | Qingyuan | Guangdong | |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | |
| Ganzhou Cancer Hospital | Ganzhou | Jiangxi |
More Sun Yat-sen University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07589049 on ClinicalTrials.gov ↗ ← All trials in China