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

NCT07649980 | Not Yet Recruiting Phase 2

• 1 other identifier: EC-2026-0002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Biliary Tract Cancer (BTC); EGFR-positive Advanced Biliary Tract Carcinoma

Keywords

Becotatug Vedotin; Pucotenlimab; EGFR-ADC; PD-1; Second-line

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

• Disease Control Rate (DCR)

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

• Duration of Response (DOR)

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

• Safety and Tolerability

  From first dose of study drug until 30 days after last dose, up to 36 months

Study Arms (1)

Becotatug Vedotin + Pucotenlimab

EXPERIMENTAL

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; Drug: Pucotenlimab

Interventions

Becotatug Vedotin DRUG

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

Also known as: MRG003

Becotatug Vedotin + Pucotenlimab

Pucotenlimab DRUG

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

Also known as: HX008

Becotatug Vedotin + Pucotenlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HuiKai Li: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Huikai Li, MD

CONTACT

86+18622228639; vianvianvip@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Professor of Oncology

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share