Becotatug Vedotin Plus Cisplatin and Radiotherapy in LA-ESCC

July 6, 2026 updated by: Jun wang, Hebei Medical University Fourth Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Fourth Hospital of Hebei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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:

    1. Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L;
    2. Hemoglobin (Hgb) ≥ 90 g/dl;
    3. Platelets (Plt) ≥ 75×10^9/L;
    4. Bilirubin total ≤ 1.5 x ULN, or bilirubin direct < ULN for patients with bilirubin total levels >1.5 ULN;
    5. AST/ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if liver metastases are present;
    6. 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. 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.
    2. History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes).
    3. Fridericia-corrected QT interval (QTcF) > 450 msec in males or > 470 msec in females.
    4. History or family history of congenital long QT syndrome.
    5. Arrhythmias requiring antiarrhythmic therapy (subjects with atrial fibrillation that has been controlled for more than 30 days prior to randomization may be enrolled).
    6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Becotatug vedotin + Cisplatin + Radiotherapy
Participants 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.
Drug: Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: Cycle 1 (21 days)
MTD is defined as the highest dose level at which DLT is observed in ≤ 1/6 subjects at one single dose group
Cycle 1 (21 days)
Recommended Phase 2 Dose (RP2D)
Time Frame: Cycle 1 (21 days)
RP2D will be a dose either below or equal to MTD
Cycle 1 (21 days)
Dose Limiting Toxicity (DLT)
Time Frame: Cycle 1 (21 days)
DLT will be evaluated according to NCI-CTCAE V5.0 criteria
Cycle 1 (21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate（ORR）
Time Frame: From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months
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)
From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months
Disease Control Rate (DCR)
Time Frame: From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months
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.
From first treatment date until disease progression or death, assessed every 6 weeks, up to approximately 36 months
Progression free survival (PFS)
Time Frame: From first treatment date to disease progression or death, up to 36 months
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.
From first treatment date to disease progression or death, up to 36 months
2-year overall survival (OS) rate
Time Frame: From first treatment date to death from any cause, assessed up to 36 months
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.
From first treatment date to death from any cause, assessed up to 36 months
Incidence and severity of adverse events (AEs)
Time Frame: From first dose date through study completion, up to 36 months
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
From first dose date through study completion, up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 20, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRG003-LA-ESCC-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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