Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Official Title

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

Keywords

Biliary Tract Cancer, HER2, HER2 expressing BTC, Trastuzumab deruxtecan, T-DXd, Rilvegostomig, Biliary Tract Neoplasms, Gemcitabine, Trastuzumab, Durvalumab, Cisplatin, Agilent HercepTest™ mAb pharmDx, Ventana PD-L1 SP263 assay, Trastuzumab deruxtecan + rilvegostomig

Eligibility

You can join if…

Open to people ages 18-99

  • Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations;
  • Male and female;
  • Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
  • histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC;
  • Provision of FFPE tumor sample that is no older than 3 years;
  • At least one target lesion assessed by the Investigator based on RECIST v1.1 (randomized portion only);
  • WHO/ECOG performance status of 0 or 1;
  • Adequate organ and bone marrow function within 14 days before randomization;
  • Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential;

You CAN'T join if...

  • Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines;
  • histologically confirmed ampullary carcinoma;
  • history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions;
  • spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
  • medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke;
  • Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment;
  • active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening;
  • Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG;
  • History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder;
  • Prior pneumonectomy (complete);
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
  • Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
  • Pregnant or breastfeeding female patients, or patients who are planning to become pregnant;
  • Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 6 months prior to randomization, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (only randomized portion).

Locations

  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site not yet accepting patients
    Glendale California 91204 United States
  • Research Site accepting new patients
    Montreal Quebec H3A 1A1 Canada
  • Research Site accepting new patients
    Halifax Nova Scotia B3H 1V7 Canada

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06467357
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 620 study participants
Last Updated