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Biliary Tract Cancer (BTC)Phase 2NCT07649980

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

A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Biliary Tract Cancer (BTC) and EGFR-positive Advanced Biliary Tract Carcinoma, run by HuiKai Li.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Becotatug Vedotin and Pucotenlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jul 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 female.
  • 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.
  • EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).
  • Failed at least one line of standard systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.
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  • At least one measurable lesion per RECIST v1.1 on CT or MRI.
  • Child-Pugh class A or B (<7 points).
  • 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.
  • No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever (>38°C) not attributable to cancer.
  • 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.
  • Expected to have good compliance with protocol-specified follow-up for efficacy and safety assessments.
  • Able to understand the study and willing to provide written informed consent.

Who cannot join

  • 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.
  • EGFR expression negative by IHC.
  • Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.
  • Psychiatric or neurological disorders that compromise the ability to comply with study procedures.
  • Prior treatment with MMAE-containing antibody-drug conjugate (ADC) therapy.
  • Planned or previous organ or bone marrow transplantation.
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  • Active or history of autoimmune disease requiring systemic immunosuppressive therapy.
  • Receipt of live vaccine within 30 days prior to first dose. Inactivated seasonal influenza vaccines are allowed.
  • Uncontrolled cardiac conditions or symptoms.
  • Active infection or fever (unless clearly attributable to tumor).
  • History or evidence of interstitial lung disease or active non-infectious pneumonitis.
  • 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.
  • Known hypersensitivity to any component of the study drugs.
  • Use of systemic immunosuppressive agents or corticosteroids (> 10 mg/day prednisone equivalent) within 14 days prior to enrollment.
  • Receipt of radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.
  • Participation in another interventional clinical trial within 4 weeks prior to enrollment.
  • Pregnancy or breastfeeding.
  • Any other condition that, in the investigator's judgment, makes the patient inappropriate for study participation.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Huikai Li, MD contact

86+18622228639

vianvianvip@163.com

About this study

Official title: 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.

Being tested
Becotatug Vedotin, Pucotenlimab
Keywords
Becotatug Vedotin, Pucotenlimab, EGFR-ADC, PD-1, Second-line
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.

  • Becotatug VedotinDrug

    Also called MRG003

    2.0mg/kg ，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

  • PucotenlimabDrug

    Also called HX008

    200mg，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

Study groups in NCT07649980
Study groupRoleWhat they receive
Becotatug Vedotin + PucotenlimabExperimentalThe 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.
Receives: Drug: Becotatug Vedotin; Drug: Pucotenlimab

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1.

    Measured: From start of treatment until disease progression, assessed up to 36 months.

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    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.

    Measured: From start of treatment to disease progression or death, assessed up to 36 months.

  2. Overall Survival (OS)

    Time from the first dose of study treatment to death from any cause.

    Measured: From start of treatment to death, assessed up to 36 months.

  3. Disease Control Rate (DCR)

    Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.

    Measured: From start of treatment until disease progression, assessed up to 36 months.

  4. Duration of Response (DOR)

    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.

    Measured: From first response to disease progression or death, assessed up to 24 months from response.

  5. Safety and Tolerability

    Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) assessed by NCI CTCAE v5.0.

    Measured: From first dose of study drug until 30 days after last dose, 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 posted16 Jun 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 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
NCT07649980
Sponsor's protocol ID
EC-2026-0002
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
16 Jun 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 2 study testing Becotatug Vedotin and Pucotenlimab in people with Biliary Tract Cancer (BTC) and EGFR-positive Advanced Biliary Tract Carcinoma, run by HuiKai Li.

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 17 inclusion and 18 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Huikai Li, MD (86+18622228639, vianvianvip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From start of treatment until disease progression, assessed up to 36 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 NCT07649980.

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 16 Jun 2026.

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