Hypopharyngeal Squamous Cell CarcinomaPhase 2RESERVE-HCNCT07665190
Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Hypopharyngeal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypopharyngeal Squamous Cell Carcinoma
- What is being tested?
- Becotatug Vedotin and Pucotenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18, male or female;
- Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;
- Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);
- 3. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy >= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.
Who cannot join
- Patients with distant metastasis;
- Patients with uncontrolled severe medical conditions;
- Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;
- Uncontrolled cardiac clinical symptoms or diseases;
- Occurrence of severe infection (CTCAE Grade > 2) within 4 weeks prior to the first dose of the study drug;
- Unexplained fever > 38.5°C during the screening period or before the first dose;
Show all 20Show fewer
- Active autoimmune disease or a history of autoimmune disease;
- History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;
- Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) must be excluded;
- History of interstitial lung disease;
- Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;
- Patients who have received any of the following treatments:
- Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose > 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;
- Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;
- Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;
- History of allergy or hypersensitivity to any component of the study treatment;
- History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years;
- Requirement for concurrent treatment with other anti-tumor therapies;
- Patients deemed unsuitable for enrollment by the investigator;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
Tianjin, Tianjin Municipality, 300060
Xudong Wang, 86+022-23340123-3130, wxd.1133@163.com
Hongling Wang, 86+022-23340123-3130, wanghongling86@163.com
About this study
Official title: A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.
The primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.
Read the detailed description
This study is a multicenter, phase II clinical trial of neoadjuvant Becotatug Vedotin (EGFR-ADC) combined with Pucotenlimab (Anti-PD-1 monoclonal antibody) in patients with resectable locally advanced hypopharyngeal squamous cell carcinoma. Eligible participants will receive Becotatug Vedotin plus Pucotenlimab as preoperative neoadjuvant therapy, intravenous infusion every 3 weeks (Q3W) for 3 cycles.Tumor assessment will be performed after two cycles of neoadjuvant treatment. If, upon evaluation by the investigator, participants achieve a complete response (CR) based on radiographic assessment after two cycles, they may proceed directly to radical surgical resection. In the event of disease progression, severe adverse events, or intolerable toxicity during the neoadjuvant phase, the investigator may decide to discontinue neoadjuvant therapy and initiate radical therapy.
- Conditions
- Hypopharyngeal Squamous Cell Carcinoma
- Being tested
- Becotatug Vedotin and 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.
Becotatug Vedotin and PucotenlimabDrug
Also called Becotatug Vedotin(MRG003), Pucotenlimab(HX008)
Neoadjuvant therapy: Becotatug Vedotin is dosed based on the participant's body weight. In this study, the dosing regimen is 2.3 mg/kg, administered via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles. The infusion time for Becotatug Vedotin should be no less than 60min, and it is recommended to be controlled within 60 to 90min. Pucotenlimab is administered at a fixed dose of 200 mg per infusion, via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles, with an infusion duration of 60min (±15 min). Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy with Becotatug Vedotin and Pucotenlimab | Experimental | Not described Receives: Drug: Becotatug Vedotin and Pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response(pCR) Rate
The proportion of participants with no residual tumor cells in the resected primary tumor specimen after the completion of neoadjuvant therapy.
Measured: At the time of surgery
Secondary outcomes (7)
Major Pathological Response(MPR) Rate
The proportion of participants who achieve a major pathological response, defined as residual viable tumor cells ≤ 10% in the resected primary tumor specimen following neoadjuvant therapy.
Measured: At the time of surgery
Objective Response Rate（ORR）
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by RECIST version 1.1 after completion of neoadjuvant therapy.
Measured: After 2 cycles or 3 cycles of neoadjuvant therapy
Event-Free Survival (EFS)
The time from the start of study treatment to the first occurrence of any of the following events, including but not limited to: disease progression precluding surgical treatment, local recurrence or distant metastasis, or death from any cause.
Measured: From start of study treatment up to approximately 3 years
Overall Survival(OS)
The time from the start of study treatment to death from any cause.
Measured: From start of study treatment up to approximately 5 years
Organ Preservation Rate
The proportion of participants in whom the surgical approach is optimized or the extent of surgery is reduced after neoadjuvant therapy, as determined by experienced surgeons comparing the feasible surgical approach based on baseline tumor assessment prior to neoadjuvant therapy with the feasible surgical approach after completion of neoadjuvant therapy.
Measured: At the time of surgery
Surgery Postponement Rate
The proportion of subjects who did not undergo radical surgery within 6 weeks after the last dose of neoadjuvant therapy.
Measured: 6 weeks after neoadjuvant therapy
Adverse Events (AEs)
Incidence, severity, and relationship to treatment of adverse events, as assessed by CTCAE criteria.
Measured: From first dose of study treatment to 1 month after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- All eligible participants will receive neoadjuvant therapy with Becotatug Vedotin plus Pucotenlimab for 3 cycles prior to surgery.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665190
- Sponsor's protocol ID
- RESERVE-HC
- Acronym
- RESERVE-HC
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07665190
- Acronym / sponsor ID
- RESERVE-HC / RESERVE-HC
- Conditions
- Hypopharyngeal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.
The primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.
Detailed description
This study is a multicenter, phase II clinical trial of neoadjuvant Becotatug Vedotin (EGFR-ADC) combined with Pucotenlimab (Anti-PD-1 monoclonal antibody) in patients with resectable locally advanced hypopharyngeal squamous cell carcinoma. Eligible participants will receive Becotatug Vedotin plus Pucotenlimab as preoperative neoadjuvant therapy, intravenous infusion every 3 weeks (Q3W) for 3 cycles.Tumor assessment will be performed after two cycles of neoadjuvant treatment. If, upon evaluation by the investigator, participants achieve a complete response (CR) based on radiographic assessment after two cycles, they may proceed directly to radical surgical resection. In the event of disease progression, severe adverse events, or intolerable toxicity during the neoadjuvant phase, the investigator may decide to discontinue neoadjuvant therapy and initiate radical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants will receive neoadjuvant therapy with Becotatug Vedotin plus Pucotenlimab for 3 cycles prior to surgery.
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy with Becotatug Vedotin and Pucotenlimab | Experimental | Drug: Becotatug Vedotin and Pucotenlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18, male or female;
- Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;
- Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);
- 3. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy >= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.
Key exclusion criteria (20 listed)
- Patients with distant metastasis;
- Patients with uncontrolled severe medical conditions;
- Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;
- Uncontrolled cardiac clinical symptoms or diseases;
- Occurrence of severe infection (CTCAE Grade > 2) within 4 weeks prior to the first dose of the study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug Vedotin and PucotenlimabAlso: Becotatug Vedotin(MRG003), Pucotenlimab(HX008)Neoadjuvant therapy: Becotatug Vedotin is dosed based on the participant's body weight. In this study, the dosing regimen is 2.3 mg/kg, administered via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles. The infusion time for Becotatug Vedotin should be no less than 60min, and it is recommended to be controlled within 60 to 90min. Pucotenlimab is administered at a fixed dose of 200 mg per infusion, via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles, with an infusion duration of 60min (±15 min). Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions. | Drug | Combination Therapy with Becotatug Vedotin and Pucotenlimab |
Primary outcome
Pathological Complete Response(pCR) Rate
Time frame: At the time of surgery
The proportion of participants with no residual tumor cells in the resected primary tumor specimen after the completion of neoadjuvant therapy.
7 secondary outcomes
Major Pathological Response(MPR) Rate
Time frame: At the time of surgery
Objective Response Rate（ORR）
Time frame: After 2 cycles or 3 cycles of neoadjuvant therapy
Event-Free Survival (EFS)
Time frame: From start of study treatment up to approximately 3 years
Overall Survival(OS)
Time frame: From start of study treatment up to approximately 5 years
Organ Preservation Rate
Time frame: At the time of surgery
Surgery Postponement Rate
Time frame: 6 weeks after neoadjuvant therapy
Adverse Events (AEs)
Time frame: From first dose of study treatment to 1 month after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingEarly Phase 1
PET/CT Assessment of Radiation-Induced Vascular Complications in Head and Neck Cancer
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Hypopharyngeal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 4 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xudong Wang (86+02223340123-3130, wxd.1133@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response(pCR) Rate (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.