AzTrials
AzTrials

Biliary Tract NeoplasmsPhase 2NCT07890311

Vedotin for Injection in Second-line or Later Treatment of Advanced Biliary Tract Cancer

A Phase 2 study testing MRG003 (Becotatug Vedotin) in people with Biliary Tract Neoplasms, run by Jiangmen Central Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Malignant tumors of the biliary system are highly invasive and malignant with an increasing incidence rate. Comprehensive drug therapy is the main treatment for advanced biliary tract tumors, yet the current gemcitabine plus platinum-based chemotherapy regimens yield suboptimal efficacy maintenance in patients with… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Biliary Tract Neoplasms
What is being tested?
MRG003 (Becotatug Vedotin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
22 Sep 2026to 22 Sep 2028
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-80 years, of any gender.
  • Patients with histologically or cytologically confirmed primary advanced biliary tract carcinoma (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), gallbladder carcinoma (GBC), and recurrent biliary tract carcinoma.
  • EGFR IHC-positive assessed by a pathological laboratory.
  • Have received at least one line of prior systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival ≥ 3 months.
Show all 15Show fewer
  • At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1.
  • Laboratory test results meeting the following criteria:
  • Hematologic function: 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 function: Creatinine ≤1.5 × upper limit of normal (ULN); creatinine clearance (Ccr) ≥55 mL/min.
  • Hepatic function: Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN. (For patients with intrahepatic cholangiocarcinoma or liver metastases: total bilirubin ≤3 × ULN; ALT and AST ≤5 × ULN).
  • 9. Absence of severe complications, such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, or non-neoplastic fever >38 °C.
  • 10. Women of child-bearing potential: agree to use contraception during the study and for 6 months after the last study treatment; have a negative serum or urine pregnancy test within 7 days prior to enrollment; and are not lactating. Male patients: agree to use contraception during the study and for 6 months after the last study treatment.
  • 11. Expected good compliance and ability to follow study procedures for efficacy and safety follow-up.
  • 12. Able to understand the study and provide written informed consent voluntarily.

Who cannot join

  • Diagnosis of other malignant tumors within the past 5 years, except for carcinoma in situ and basal cell carcinoma.
  • Known central nervous system metastases (excluding patients with stable, asymptomatic disease 4 weeks after radiotherapy or surgery), or evidence of carcinomatous meningitis.
  • Psychiatric or neurological disorders that may impair subject compliance with study requirements.
  • Prior treatment with MMAE-payload antibody-drug conjugates (ADCs).
  • Planned or prior organ or bone marrow transplantation.
  • Administration of live vaccines within 30 days before the first study drug dose. Inactivated seasonal injectable influenza vaccine is permitted.
Show all 15Show fewer
  • Uncontrolled clinically significant cardiac signs or diseases.
  • Active infection or fever (excluding documented tumor-related fever).
  • History or evidence of interstitial lung disease or active non-infectious pneumonitis.
  • Other medical conditions rendering the subject ineligible for enrollment, including immunodeficiency, active pulmonary tuberculosis, positive hepatitis C virus test, uncorrectable electrolyte disturbances, uncontrolled pericardial, pleural or peritoneal effusion. Patients with hepatitis B may be enrolled if HBV-DNA < 500 IU/mL and liver function is normal after treatment.
  • Known hypersensitivity to any study drug or its excipients.
  • Receipt of radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks prior to enrollment.
  • Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
  • Pregnant or lactating women.
  • Subjects deemed inappropriate for enrollment at the investigator's discretion.

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

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Open-label, Phase II Clinical Study of Vedotin for Injection as Second-line or Later Treatment for Advanced Biliary Tract Cancer.

Malignant tumors of the biliary system are highly invasive and malignant with an increasing incidence rate. Comprehensive drug therapy is the main treatment for advanced biliary tract tumors, yet the current gemcitabine plus platinum-based chemotherapy regimens yield suboptimal efficacy maintenance in patients with advanced biliary tract tumors. There is an urgent need for effective second-line treatment regimens for advanced biliary tract tumors. Vicinecumab is a recombinant humanized anti-EGFR monoclonal antibody generated by conjugating a potent cytotoxic small molecule to trastuzumab. It inhibits tumor cell proliferation and promotes tumor cell death by blocking various cellular physiological functions including mitosis. Current research data have demonstrated that in patients with recurrent and metastatic nasopharyngeal carcinoma who have received systemic therapy, vicinecumab can significantly improve patients' survival and prognosis compared with the chemotherapy group, with a manageable safety profile. Therefore, this study aims to observe and evaluate the efficacy and safety of vicinecumab in the second-line and subsequent treatment of advanced biliary tract tumors.

Being tested
MRG003 (Becotatug Vedotin)
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • MRG003 (Becotatug Vedotin)Biological

    Becotatug vedotin 2.3 mg/kg, intravenous infusion over 60 minutes (±15 min), Q3W (every 21 days).

Study groups in NCT07890311
Study groupRoleWhat they receive
Experimental: MRG003 (Becotatug vedotin)ExperimentalNot described
Receives: Biological: MRG003 (Becotatug Vedotin)

What is being measured

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

  1. Objective Response Rate

    ORR assessed by investigator according to RECIST version 1.1 (CR + PR).

    Measured: From first study drug administration until documented disease progression or death, up to approximately 24 months.

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Time from first dose to first documented disease progression (RECIST 1.1) or death from any cause.

    Measured: Up to approximately 24 months.

  2. Disease Control Rate (DCR)

    Percentage of participants with CR, PR or SD per RECIST 1.1.

    Measured: From first dose until disease progression, up to approximately 24 months.

  3. Time from first dose to death from any cause.

    Time from first dose to death from any cause.

    Measured: Up to approximately 30 months.

  4. Safety-Incidence of Adverse Events (AEs) and Serious Adverse Events

    Incidence, severity (NCI-CTCAE v5.0) of AEs/SAEs, laboratory abnormalities, vital-sign changes.

    Measured: From signing informed consent through 30 days after last study drug dose.

Timeline

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

  1. First posted22 Oct 2026
  2. Study start22 Sep 2026
  3. Primary completion22 Sep 2027 (estimated)
  4. Study completion22 Sep 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890311
Sponsor's protocol ID
2026084Ayu
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
26 Oct 2026
Results posted
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 2 study testing MRG003 (Becotatug Vedotin) in people with Biliary Tract Neoplasms, run by Jiangmen Central 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 15 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 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 (time frame: From first study drug administration until documented disease progression or death, up to approximately 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 NCT07890311.

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 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in