Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies

Sichuan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Cancer of Biliary Duct

Treatments: Drug: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors

Study type: Interventional

Funder types: Other

Identifiers

NCT07472933

2026（225）

Details and patient eligibility

About

This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 - 70 years old, gender not restricted;

2. Patients with untreated primary advanced biliary system malignancies diagnosed by pathological histology or cytology;

3. Physical condition: ECOG PS score 0 - 1;

4. Pathological laboratory assessment: EGFR IHC ≥ 1+;

5. Have undergone at least one line of systemic drug treatment;

6. According to the RECIST 1.1 standard, at least one measurable target lesion that can be detected by CT or MRI;

7. Laboratory test indicators meet the following requirements:

   ① Bone marrow function: Hemoglobin (Hb) ≥ 90g/L; White blood cell count (WBC) ≥ lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L;

   ② Renal function: Cr ≤ UNL (upper limit of normal) × 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;

   ③ Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 2.5; (if it is intrahepatic cholangiocarcinoma or there is liver metastasis, total bilirubin not higher than 3 times the upper limit of normal, transaminase not higher than 5 times the upper limit of normal);

   ④ Coagulation function: International normalized ratio of prothrombin time ≤ ULN × 1.5, and partial thromboplastin time within the normal range;

8. Pregnant women agree to use contraception during the study period and within 6 months after the study ends; The serum or urine pregnancy test is negative within 7 days before the study entry, and non-lactating patients; Male patients agree to use contraception during the study period and within 6 months after the study ends;

9. Within 4 weeks before entry, have not participated in other drug clinical trials;

10. The subject can understand the situation of this study and voluntarily sign the informed consent form.

11. No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38℃;

12. Expected good compliance, able to follow the protocol requirements for efficacy and adverse reactions follow-up.

13. Expected survival period > 3 months.

Exclusion criteria

(1) Previously diagnosed with other malignant tumors within 5 years (excluding carcinoma in situ, basal cell carcinoma, etc.); (2) Known central nervous system metastasis (except for those with stable disease after radiotherapy or surgery for 4 weeks and no symptoms) or evidence of cancer meningitis; (3) Have mental or neurological disorders and cannot cooperate; (4) Patients who have received drugs with a loading dose of MMAE ADC drugs previously; (5) Patients preparing for or having previously received organ or bone marrow transplantation; (6) Have any active autoimmune diseases or autoimmune disease history; (7) Received live vaccines within 30 days before the first administration (allowing the use of injectable seasonal influenza vaccine as it is a killed vaccine); (8) Have uncontrolled clinical symptoms or diseases of interstitial lung disease or active non-infectious pneumonia history or evidence; (9) Have interstitial lung disease or active non-infectious pneumonia history or evidence within 4 weeks before entry; (10) Have other diseases that are not suitable for entry, such as immunodeficiency, active pulmonary tuberculosis, hepatitis B (with HBV-DNA < 500IU/ml and normal liver function after treatment can be enrolled), hepatitis C virus positive, uncorrectable electrolyte disorders, uncontrollable pericardial effusion, pleural effusion and ascites, etc.; (11) Allergic to any drug in this protocol; (12) Within 14 days before entry, used immunosuppressive drugs or corticosteroids > 10mg/day prednisone at the efficacy dose; (13) Within 4 weeks before entry, received radiotherapy, chemotherapy, targeted therapy or immunotherapy; (14) Pregnant or lactating women; The researchers considered those who were not suitable for inclusion in the study.

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Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Vibecototamab combined with Putilimab

Experimental group

Description:

This study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR.

Treatment:

Drug: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors