Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II

June 10, 2026 updated by: HuiKai Li

Becotatug Vedotin Combined With Pucotenlimab in First-Line Treatment-Failed Advanced Biliary Tract Carcinoma: A Phase II Exploratory Clinical Study

Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.

This open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years, male or female.
  2. Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.
  3. EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).
  4. Failed at least one line of standard systemic therapy.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Life expectancy ≥ 3 months.
  7. At least one measurable lesion per RECIST v1.1 on CT or MRI.
  8. Child-Pugh class A or B (<7 points).

  9. Adequate organ function as defined below:

    • Hematologic: Hemoglobin (Hb) ≥ 90 g/L; white blood cell count (WBC) ≥ lower limit of normal (LLN); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L.
    • Renal: Serum creatinine ≤ 1.5 × upper limit of normal (ULN); creatinine clearance (CrCl) ≥ 55 mL/min.
    • Hepatic: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (or ≤ 3 × ULN for total bilirubin and ≤ 5 × ULN for ALT/AST in patients with intrahepatic cholangiocarcinoma or liver metastases).
    • Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; partial thromboplastin time (PTT) within normal range.
  10. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever (>38°C) not attributable to cancer.
  11. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the last dose. Male participants must agree to use effective contraception during the study and for 6 months after the last dose.
  12. Expected to have good compliance with protocol-specified follow-up for efficacy and safety assessments.
  13. Able to understand the study and willing to provide written informed consent.

Exclusion Criteria:

  1. Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.
  2. EGFR expression negative by IHC.
  3. Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.
  4. Psychiatric or neurological disorders that compromise the ability to comply with study procedures.
  5. Prior treatment with MMAE-containing antibody-drug conjugate (ADC) therapy.
  6. Planned or previous organ or bone marrow transplantation.
  7. Active or history of autoimmune disease requiring systemic immunosuppressive therapy.
  8. Receipt of live vaccine within 30 days prior to first dose. Inactivated seasonal influenza vaccines are allowed.
  9. Uncontrolled cardiac conditions or symptoms.
  10. Active infection or fever (unless clearly attributable to tumor).
  11. History or evidence of interstitial lung disease or active non-infectious pneumonitis.
  12. Any other condition that makes the patient unsuitable for enrollment, including but not limited to: immunodeficiency; active tuberculosis; hepatitis B (eligible if HBV-DNA < 500 IU/mL with normal liver function after antiviral therapy); hepatitis C virus (HCV) infection; uncorrectable electrolyte disturbances; uncontrolled pericardial effusion, pleural effusion, or ascites.
  13. Known hypersensitivity to any component of the study drugs.
  14. Use of systemic immunosuppressive agents or corticosteroids (> 10 mg/day prednisone equivalent) within 14 days prior to enrollment.
  15. Receipt of radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.
  16. Participation in another interventional clinical trial within 4 weeks prior to enrollment.
  17. Pregnancy or breastfeeding.
  18. Any other condition that, in the investigator's judgment, makes the patient inappropriate for study participation.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Becotatug Vedotin + Pucotenlimab
The combination regimen will be continued until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.
Drug: Becotatug Vedotin
2.0mg/kg ，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.
Other Names:
  • MRG003
Drug: Pucotenlimab
200mg，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.
Other Names:
  • HX008

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From start of treatment until disease progression, assessed up to 36 months.
Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1.
From start of treatment until disease progression, assessed up to 36 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From start of treatment to disease progression or death, assessed up to 36 months.
Time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
From start of treatment to disease progression or death, assessed up to 36 months.
Overall Survival (OS)
Time Frame: From start of treatment to death, assessed up to 36 months.
Time from the first dose of study treatment to death from any cause.
From start of treatment to death, assessed up to 36 months.
Disease Control Rate (DCR)
Time Frame: From start of treatment until disease progression, assessed up to 36 months.
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
From start of treatment until disease progression, assessed up to 36 months.
Duration of Response (DOR)
Time Frame: From first response to disease progression or death, assessed up to 24 months from response.
Time from the first documented objective response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
From first response to disease progression or death, assessed up to 24 months from response.
Safety and Tolerability
Time Frame: From first dose of study drug until 30 days after last dose, up to 36 months
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) assessed by NCI CTCAE v5.0.
From first dose of study drug until 30 days after last dose, up to 36 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HuiKai Li

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC-2026-0002

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

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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