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Esophageal Squamous Cell CarcinomaPhase 1NCT07697040

Becotatug Vedotin Plus Cisplatin and Radiotherapy in LA-ESCC

A Phase 1 study testing Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.

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

This study is a prospective, single-arm, single-center Phase Ib clinical trial of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Jul 2026to 31 Dec 2029
Phase
Phase 1
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

  • Subjects who are able to understand and voluntarily sign informed consent forms (ICFs).
  • Male and female subjects at the age of ≥18 and ≤75 at the time of screening.
  • Histologically confirmed esophageal squamous cell carcinoma staged as cT2-T4a, N0-N+, M0-M1 (M1 limited to supraclavicular lymph node metastasis only).
  • Patients must have at least one measurable lesion as defined by RECIST version 1.1 criteria.
  • Patients who have not received any prior anti-tumor treatment for esophageal cancer.
  • ECOG score of 0 or 1.
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  • Life expectancy ≥ 3 months.
  • Adequate organ function (no blood transfusion and no use of granulocyte colony-stimulating factor, or other hematopoietic stimulator support within 2 weeks before the first administration of the study drug) confirmed as evidenced by:
  • Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L;
  • Hemoglobin (Hgb) ≥ 90 g/dl;
  • Platelets (Plt) ≥ 75×10^9/L;
  • Bilirubin total ≤ 1.5 x ULN, or bilirubin direct < ULN for patients with bilirubin total levels >1.5 ULN;
  • AST/ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if liver metastases are present;
  • Serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (as calculated via Cockcroft-Gault formula based on the actual body weight of the subject ;
  • Female subjects must not be pregnant or breastfeeding. Female or male subjects of childbearing potential must agree to practice effective contraceptive measures throughout the study period and for 6 months after completion of study treatment.

Who cannot join

  • Diagnosis of any other malignancy within the past 5 years (excluding carcinoma in situ, basal cell carcinoma, etc.).
  • Anyone allergic to any drug or any of its components in this regimen.
  • Patients with a prior history of surgery for esophageal squamous cell carcinoma.
  • Patients with a prior history of fistula caused by primary tumor infiltration.
  • Patients at high risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
  • Subjects with poor nutritional status, defined as BMI < 18.5 kg/m² or PG-SGA score ≥ 9.
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  • Patients with a diagnosis of pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
  • Active infections such as HIV; active chronic HBV/HCV (e.g., HBV DNA ≥ 10⁴ copies/mL or ≥ 2000 IU/mL) requiring antiviral and hepatoprotective therapy before enrollment. Enrollment is allowed only when HBV DNA decreases to < 10⁴ copies/mL or < 2000 IU/mL, with continued antiviral therapy and regular monitoring of liver function and HBV DNA levels.
  • Presence of major cardiovascular disease, including any of the following conditions:
  • Congestive heart failure (defined as New York Heart Association [NYHA] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery bypass grafting, cerebrovascular accident (CVA), or hypertensive crisis within 6 months prior to enrollment.
  • History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes).
  • Fridericia-corrected QT interval (QTcF) > 450 msec in males or > 470 msec in females.
  • History or family history of congenital long QT syndrome.
  • Arrhythmias requiring antiarrhythmic therapy (subjects with atrial fibrillation that has been controlled for more than 30 days prior to randomization may be enrolled).
  • History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to enrollment (thrombosis related to an implanted venous access port or catheter, or superficial venous thrombosis, is not considered "serious" thromboembolism).
  • Severe chronic diarrhea.
  • Severe psychiatric disorder.
  • Use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1.
  • Participation in another clinical trial within 4 weeks prior to enrollment.
  • Patients who, in the opinion of the investigator, are unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

YunJie Cheng contact

+8613633115261

jiekejaker@sina.com

China1 site

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Jun Wang, 0311-86095794, wangjunzr@163.com

Other trials in China

About this study

Official title: A Phase Ib, Open-Label, Single-Arm Study of Becotatug Vedotin Combined With Cisplatin and Concurrent Radiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

This study is a prospective, single-arm, single-center Phase Ib clinical trial of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The primary objectives are to investigate the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended Phase II dose (RP2D) of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The secondary objectives are to assess the efficacy and safety of this combination regimen.

Read the detailed description

This study is a prospective, open-label, single-center, dose-escalation Phase I clinical trial. During the dose-escalation phase, the classic "3+3" design will be used to guide dose escalation in order to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Eligible subjects who meet the inclusion and exclusion criteria will receive two cycles of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy, followed by subsequent systemic therapy per the investigator's discretion. The dose levels of Becotatug Vedotin are 1.5 mg/kg, 2.0 mg/kg, and 2.3 mg/kg (D1,IV,Q3W). Cisplatin is administered at a dose of 75 mg/m² (D1,IV,Q3W). The total radiotherapy dose is 50.4 Gy, delivered in 28 fractions of 1.8 Gy each. Dose-limiting toxicities (DLTs) will be observed during the treatment period until the completion of the entire concurrent chemoradiotherapy phase.

Being tested
Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy
Keywords
Becotatug vedotin (EGFR-ADC）, LA-ESCC, Cisplatin and Concurrent Radiotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Becotatug Vedotin Combined with Cisplatin and Concurrent RadiotherapyDrug

    • Becotatug Vedotin：1.5mg/kg 、2.0mg/kg、2.3mg/kg，d1;IV; Q3W
    • Cisplatin：75mg/m2，d1;IV; Q3W
    • Radiotherapy：50.4Gy/28f/1.8Gy
Study groups in NCT07697040
Study groupRoleWhat they receive
Becotatug vedotin + Cisplatin + RadiotherapyExperimentalParticipants receive Becotatug vedotin (MRG003) in combination with Cisplatin and concurrent radiotherapy. During the dose-escalation phase, the classic "3+3" design will be used to guide dose escalation in order to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Eligible subjects who meet the inclusion and exclusion criteria will receive two cycles of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy, followed by subsequent systemic therapy per the investigator's discretion.
Receives: Drug: Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    MTD is defined as the highest dose level at which DLT is observed in ≤ 1/6 subjects at one single dose group

    Measured: Cycle 1 (21 days)

  2. Recommended Phase 2 Dose (RP2D)

    RP2D will be a dose either below or equal to MTD

    Measured: Cycle 1 (21 days)

  3. Dose Limiting Toxicity (DLT)

    DLT will be evaluated according to NCI-CTCAE V5.0 criteria

    Measured: Cycle 1 (21 days)

Secondary outcomes (5)

  1. Objective response rate（ORR）

    Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)

    Measured: From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST 1.1 criteria, among the total number of evaluable patients.

    Measured: From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months

  3. Progression free survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from randomization (or first dose of study treatment) to the first documented disease progression per RECIST 1.1 criteria, or death from any cause, whichever occurs first.

    Measured: From first treatment date to disease progression or death, up to 36 months

  4. 2-year overall survival (OS) rate

    The 2-year overall survival (OS) rate is defined as the percentage of patients who remain alive at 2 years after the start of study treatment.

    Measured: From first treatment date to death from any cause, assessed up to 36 months

  5. Incidence and severity of adverse events (AEs)

    severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0

    Measured: From first dose date through study completion, up to 36 months

Timeline

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

  1. First posted10 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion31 Dec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697040
Sponsor's protocol ID
MRG003-LA-ESCC-013
Status last verified
Jun 2026
First submitted
20 Jun 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth 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 15 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: opening soon, as of the sponsor's last update on 10 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 YunJie Cheng (+8613633115261, jiekejaker@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Cycle 1 (21 days)). The study lists 3 primary outcomes in all. 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 NCT07697040.

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 10 Jul 2026.

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