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Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer

NCT07670273 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-26

No results posted yet for this study

Summary

This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.

Conditions

  • Biliary Tract Neoplasms Immunotherapy

Interventions

DRUG

Trastuzumab Rezetecan

The recommended dosage is 4.8 mg/kg. A fixed dose of 408 mg is administered for patients weighing ≥85 kg. It is given via intravenous infusion every 3 weeks (Q3W). The first infusion should be administered over 90 minutes. If the prior infusion was well-tolerated, subsequent infusions may be shortened to 30 minutes.

DRUG

Adebrelimab

A fixed dose of 1200 mg is administered via intravenous infusion every 3 weeks (±3 days). The infusion duration should be controlled between 30 and 60 minutes and must not exceed 2 hours.

DRUG

Lenvatinib

Administered orally once daily with food (preferably at the same time each day). The dose is 12 mg/day for patients weighing ≥60 kg and 8 mg/day for those \<60 kg. The dose can be de-escalated based on toxicity according to the following scheme: 12 mg/day → 8 mg/day → 4 mg/day → discontinuation. If the investigator deems the patient intolerant, dose reduction across levels may be considered if deemed necessary.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2027-04-29
Completion
2028-04-29

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670273 on ClinicalTrials.gov