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Locally Advanced Oral and Oropharyngeal Squamous Cell CarcinomaPhase 2NCT07545083

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC)

A Phase 2 study testing MRG003+Pucotenlimab in people with Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of Becotatug Vedotin with Pucotenlimab as a possible neoadjuvant therapyand for locally advanced oral/pharyngeal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MRG003+Pucotenlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Apr 2026to Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histologically or cytologically confirmed oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) >1, EGFR expression score (IHC) >90%+.
  • Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET/CT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+/- chemotherapy.
  • Age ranges from 18 to 75 years old.
  • ECOG performance status 0 or 1.
  • Expected survival ≥ 3 months.
  • Participants must have not received treatment for before.
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  • There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.
  • The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and/or confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 ^ 9/L; Neutrophil count (NEUT) ≥ 1.5 × 10 ^ 9/L, platelet count (PLT) ≥ 100 × 10 ^ 9/L, hemoglobin (Hb) ≥ 90 g/L; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
  • The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Who cannot join

  • Squamous cell carcinoma with primary site of nasopharynx or skin.
  • Diagnosed with malignant diseases other than head and neck squamous cell carcinoma within 3 years before the first administration (excluding Radical treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative excised carcinoma in situ)
  • Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
  • Has received live or attenuated vaccines within 30 days prior to the first dose of Sintilimab, inactivated vaccines are allowed.
  • Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.
  • Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen [HBsAg]) or known history of active hepatitis C virus (defined as detection of HCV RNA [qualitative]) infection; - - Has a known history of human immunodeficiency virus (HIV) infection.
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  • Has received allogeneic tissue/solid organ transplantation.
  • Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2) with the exception of alopecia.
  • Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。
  • Has severe clinical infection (>NCI-CTCAE 5.0 Level 2 infection);
  • Has uncontrollable hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.
  • Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has participated in other clinical studies within 30 days prior to enrollment.
  • Other situations that researchers consider unsuitable for participation in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tong Ji, PhD contact

86-13651658767

ji.tong@zs-hospital.sh.cn

Chengzhong Lin, PhD contact

86-18916535332

lin.chengzhong@zs-hospital.sh.cn

About this study

Official title: A Single-Arm, Prospective Phase II Clinical Study of Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of Becotatug Vedotin with Pucotenlimab as a possible neoadjuvant therapyand for locally advanced oral/pharyngeal squamous cell carcinoma.

Read the detailed description

Approximately 60% of patients with oral/oropharyngeal squamous cell carcinoma (OSCC) are found to be in the local advanced stage. Even if they actively undergo comprehensive sequential treatment such as surgery, radiotherapy, and chemotherapy, the 5-year survival rate is still less than 50%. According to both the NCCN and the CSCO head and neck cancer treatment guidelines, radical surgery is the main treatment strategy for locally advanced OSCC, and adjuvant radiotherapy or chemotherapy/radiotherapy. However, the high treatment failure rate and disease recurrence rate are still the fundamental reasons for its poor prognosis. In recent years, neoadjuvant therapy has been proven to reduce the burden of local diseases in multiple tumor types, thereby improving surgical outcomes, reducing the risk of distant metastasis, and predicting prognosis based on the patient's pathological response. The combination of anti-PD-1/PD-L1 monoclonal antibodies and EGFR ADC drugs has a synergistic anti-tumor effect, and this combination therapy is worth exploring in the neoadjuvant treatment of locally advanced oral/oropharyngeal squamous cell carcinoma. This prospective, open label, single arm, phase II, single center exploratory study aims to evaluate the efficacy and safety of the combination therapy of Becotatug Vedotin and Pucotenlimab as neoadjuvant therapy in patients with locally advanced oral/oropharyngeal squamous cell carcinoma.

Being tested
MRG003+Pucotenlimab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG003+PucotenlimabDrug

    The participants will receive Pucotenlimab 200 mg (each 3-week/cycle) and Becotatug Vedotin (2.3mg/kg, each 3-week/cycle) for 2 cycles bofore surgery

Study groups in NCT07545083
Study groupRoleWhat they receive
combined treatmentExperimentalBecotatug Vedotin + Pucotenlimab
Receives: Drug: MRG003+Pucotenlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Major Pathological Response (mPR)

    Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR

    Measured: 2 months

Secondary outcomes (6)

  1. Rate of Pathologic complete response (pCR)

    Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.

    Measured: 2 months

  2. 1 year Event-free Survival (EFS) Rate

    EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1

    Measured: 12 months

  3. 1 year Overall Survival (OS) Rate

    OS is the time from study entry to death due to any cause

    Measured: 12 months

  4. 2 year Event-free Survival (EFS) Rate

    Measured: 24 months

  5. 2 year Overall Survival (OS) Rate

    Measured: 24 months

  6. Adverse Events (AEs)

    Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07545083
Sponsor's protocol ID
B2026-172R
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG003+Pucotenlimab in people with Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tong Ji, PhD (86-13651658767, ji.tong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Major Pathological Response (mPR) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07545083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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