Phase 3: testing Gemcitabine for Biliary Tract Cancer
This study wants to measure the how well it works and safety of T-DXd with rilvegostomig or T-DXd this drug alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Official registry: https://clinicaltrials.gov/study/NCT06467357 · AstraZeneca · enrollment listed as 620
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Gemcitabine, Cisplatin, or Durvalumab. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of T-DXd with rilvegostomig or T-DXd this drug alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
They plan to enroll about 620 people at 223 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan, Rilvegostomig
Primary outcome (registry wording): Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
Who it is for (from inclusion criteria)
- Ages 18 Years to 99 Years
- Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC
- Patients must provide an FFPE tumor sample that is no older than 3 years
- Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (randomly assigned portion only)
- WHO/how well you can do daily activities (ECOG score) of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
- 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
- Minimum life expectancy of 12 weeks
Who the registry excludes
- Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines
- Histologically confirmed ampullary carcinoma
- Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results
- 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
- 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
Public study contact (from the registry)
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
223 listed- Research Site — Scottsdale, Arizona (recruiting)
- Research Site — Tucson, Arizona (withdrawn)
- Research Site — Fullerton, California (recruiting)
- Research Site — La Jolla, California (recruiting)
- Research Site — Los Alamitos, California (suspended)
- Research Site — Los Angeles, California (recruiting)
- Research Site — San Francisco, California (recruiting)
- Research Site — Walnut Creek, California (withdrawn)
- Research Site — Washington D.C., District of Columbia (not_yet_recruiting)
- Research Site — Fort Myers, Florida (recruiting)
- Research Site — Jacksonville, Florida (recruiting)
- Research Site — St. Petersburg, Florida (recruiting)
+ 182 sites outside the US on the same record
FAQ about this NCT record
Is NCT06467357 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06467357?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06467357?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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