NCT06467357 · AstraZeneca
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
(DESTINY-BTC01)
What this study is about
The purpose of this study is to measure the effectiveness and safety of T-DXd with rilvegostomig or T-DXd treatment given alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
View original scientific description
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.
Interventions
DRUG
Gemcitabine
Standard of care chemotherapy by intravenous infusion
DRUG
Cisplatin
Standard of care chemotherapy by intravenous infusion
DRUG
Durvalumab
Standard of care immunotherapy by intravenous infusion
DRUG
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
DRUG
Rilvegostomig
Experimental therapy by intravenous infusion
Primary outcome measures
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
Time frame: Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.
Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population
Time frame: From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Overall survival (OS) in FAS (HER2 IHC 3+) population OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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; Key
Exclusion criteria
- Prior exposure to other HER2 targeting therapi
Where
- Scottsdale, Arizona
- Tucson, Arizona
- Fullerton, California
- La Jolla, California
- Los Alamitos, California
- Los Angeles, California
- San Francisco, California
- Walnut Creek, California
- Washington D.C., District of Columbia
- Fort Myers, Florida
- Jacksonville, Florida
- St. Petersburg, Florida
And 29 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations