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A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07707167 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-16

No results posted yet for this study

Summary

This is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC).

\*\*Neoadjuvant Phase\*\* (3-week cycle, 2 cycles):

* Putlimab (HX008): 200 mg, Q3W, D1, IV
* Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV

\*\*Adjuvant/Maintenance Phase:\*\* Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion.

\*\*Group A (Postoperative pCR):\*\*

* Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
* Adjuvant RT: 40 Gy/5 weeks

\*\*Group B (Postoperative MPR):\*\*

* Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year
* Adjuvant RT: 50 Gy/5 weeks

\*\*Group C (Postoperative Partial/No Response):\*\*

* Low-risk (no extracapsular nodal extension \[ENE\] and negative margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60 Gy/6 weeks
* High-risk (ENE and/or positive margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60-66 Gy/6-6.6 weeks + Cisplatin 60 mg/m², Q3W, D1, IV, for 2 cycles

RT timing, field, and fractionation may be adjusted by investigators based on individual disease status.

Imaging assessment every 2 cycles (±7 days) until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated.

Conditions

  • LA HNSCC

Interventions

DRUG

Pucotenlimab

Neoadjuvant Phase: All subjects will receive 2 cycles of Putlimab (HX008): 200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min). Adjuvant Phase: All subjects will receive Putlimab for up to 1 year，200 mg, Q3W, D1, IV (60 ± 15 min, first cycle infusion ≥ 60 min).

DRUG

Becotatug vedotin

Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV(60 ± 15 min, first cycle infusion ≥ 60 min).

RADIATION

Radiotherapy

Adjuvant Phase: All subjects will receive varying degrees of chemoradiotherapy based on their pathological response and nodal involvement status. Group A (Postoperative pCR): RT 40 Gy/5 weeks. \*\*Group B (Postoperative MPR): RT 50 Gy/5 weeks.；Group C (Postoperative Partial Response/No Response): (1) Low/Intermediate-risk subjects (no extracapsular nodal extension \[ENE\] and negative margins): RT 60 Gy/6 weeks; (2) High-risk subjects (ENE and/or positive margins): RT 60-66 Gy/6-6.6 weeks combined with cisplatin. RT timing, field, and fractionation may be adjusted by investigators based on individual disease status.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • China

Study Locations

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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 NCT07707167 on ClinicalTrials.gov