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ESCCPhase 2NCT07531979

Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2

A Phase 2 study testing Tislelizumab, Becotatug Vedotin and Cisplatin in people with ESCC and Tislelizumab, run by Tianjin Medical University Cancer Institute and 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

Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ESCC, Tislelizumab, Chemotherapy
What is being tested?
Tislelizumab, Becotatug Vedotin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
1 Apr 2026to 31 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Male or non-pregnant, non-lactating female.
  • ECOG performance status of 0 or 1, with no deterioration within 7 days.
  • Histologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma.
  • No prior systemic therapy for ESCC. Patients who have received neoadjuvant or adjuvant therapy must have experienced disease progression or recurrence more than 6 months after completion of that treatment.
  • Patients with metastatic disease must have at least one measurable lesion per RECIST 1.1 criteria; patients with disease after neoadjuvant therapy must have an evaluable lesion.
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  • Adequate organ and bone marrow function, as demonstrated by the following laboratory values:
  • Hemoglobin (HGB) ≥ 90 g/L.
  • Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹/L.
  • Platelet count (PLT) ≥ 80 × 10⁹/L.
  • Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN.
  • Creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
  • Urine protein < (++) or 24-hour urinary protein < 1.0 g.
  • Normal coagulation function and no active bleeding:
  • International Normalized Ratio (INR) ≤ 1.5.
  • Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
  • For women of childbearing potential: negative pregnancy test (serum or urine) within 14 days prior to enrollment, and agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug. For men: surgically sterile or agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug.
  • Expected survival ≥ 6 months.
  • Patient voluntarily participates in the study and signs the informed consent form (ICF).
  • Patient is expected to be compliant and able to undergo follow-up for efficacy and adverse events as required by the protocol.

Who cannot join

  • Patients meeting any of the following criteria at screening will be excluded from the study:
  • Prior treatment with any anti-EGFR monoclonal antibody, or with anti-PD-1/PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or any other drug/antibody targeting T-cell co-stimulation or checkpoint pathways.
  • Administration of a live vaccine within 4 weeks prior to enrollment or anticipated during the study period.
  • Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.
  • Prior allogeneic bone marrow transplantation or solid organ transplant.
  • Uncontrolled hypertension at enrollment, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
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  • Any disease or condition affecting drug absorption at enrollment.
  • Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction within 6 months prior to enrollment; severe/unstable angina or coronary artery bypass grafting; congestive heart failure > New York Heart Association (NYHA) Class 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) < 50%.
  • Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2 infection).
  • Known HIV infection. Known clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, i.e., HBV DNA positive (>1×10⁴ copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection with HCV RNA positive (>1×10³ copies/mL)].
  • Any other disease, clinically significant metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, reasonably suggests the presence of a disease or condition that contraindicates the use of the investigational drug (e.g., a condition associated with seizures requiring treatment), would affect the interpretation of study results, or would place the patient at high risk.
  • Patients deemed by the investigator to be 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.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

Other trials in China

About this study

Official title: A Prospective, Open-label, Multicohort, Phase II Clinical Study of Becotatug Vedotin in Combination With Tislelizumab and Chemotherapy for Esophageal Squamous Cell Carcinoma

Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy.

The epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.

Being tested
Tislelizumab, Becotatug Vedotin, Cisplatin

What participants receive

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

  • TislelizumabDrug

    Tislelizumab 200mg IV Q3W + Followed by maintenance treatment for 2 year (Tislelizumab 200 mg IV Q3W for 6 cycles and Tislelizumab 200 mg Q3W for 28 cycles)

  • Becotatug VedotinDrug

    2mg/kg or 2.3mg/kg，D1，Q3W, 6 cycles

  • CisplatinDrug

    60mg/㎡, D1, Q3W, 6 cycles

  • TislelizumabDrug

    Tislelizumab 200mg IV Q3W + Followed by adjuvant treatment for 1 year (Tislelizumab 200 mg IV Q3W for 3 cycles and Tislelizumab 200 mg Q3W for 14 cycles)

  • Becotatug VedotinDrug

    2mg/kg or 2.3mg/kg，D1，Q3W，3 cycles

  • CisplatinDrug

    60mg/㎡ , D1，Q3W, 3 cycles

Study groups in NCT07531979
Study groupRoleWhat they receive
Arm A: first-line treatment for advanced cohortExperimentalTislelizumab + Becotatug Vedotin + cisplatin (for up to 6 cycles), followed by tislelizumab monotherapy as maintenance treatment (for up to 2 years).
Receives: Drug: Tislelizumab; Drug: Becotatug Vedotin; Drug: Cisplatin
Arm B: preoperative neoadjuvant therapy cohortExperimentalTislelizumab + Becotatug Vedotin + cisplatin (for 3 cycles), followed by tislelizumab monotherapy as adjuvant treatment after surgery (for up to 1 year)
Receives: Drug: Tislelizumab; Drug: Becotatug Vedotin; Drug: Cisplatin

What is being measured

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

  1. Objective Response Rate (ORR)

    The Overall Response Rate (ORR): is defined as the proportion of patients who achieved complete response (CR) or partial response (PR) as the best response during the treatment. evaluated by the investigator according to RECIST 1.1 criteria.

    Measured: up to 24 months

Secondary outcomes (9)

  1. Arm A：Disease Control Rate (DCR)

    Measured: up to 24 months

  2. Arm B: Pathological Complete Response (pCR) rate

    Measured: up to 24 months

  3. Arm A: Progression Free Survival (PFS)

    Measured: up to 24 months

  4. Arm A: Overall Survival (OS)

    Measured: up to 48 months

  5. Arm A: Adverse Events (AE)

    Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests

    Measured: up to 36 months

  6. Arm B：Major Pathological Response (MPR) rate

    Measured: up to 24 months

  7. Arm B： R0 resection rate

    Measured: up to 24 months

  8. Arm B：OS

    Measured: up to 48 months

  9. Arm B：Adverse Events (AE)

    Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests

    Measured: 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 posted15 Apr 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Mar 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study comprises two cohorts: Cohort 1 consists of patients with treatment-naïve advanced or metastatic ESCC, and Cohort 2 consists of patients with locally advanced ESCC.
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531979
Sponsor's protocol ID
PROGRESS
Status last verified
Feb 2026
First submitted
16 Mar 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Becotatug Vedotin and Cisplatin in people with ESCC and Tislelizumab, 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 21 inclusion and 12 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 15 Apr 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 24 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 NCT07531979.

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 15 Apr 2026.

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