Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

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Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase III
Eligibility
18 - 99 Years, Male and Female
Study Type
Treatment
NCT ID
NCT06467357
Protocol IDs
D781PC00001 (primary)
NCI-2024-08124
2023-508057-19-00
Study Sponsor
AstraZeneca Pharmaceuticals LP

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.

Eligibility

  1. Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.
  2. Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
  3. Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
  4. Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.
  5. Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)
  6. WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  7. Adequate organ and bone marrow function within 14 days before randomization.
  8. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
  9. Minimum life expectancy of 12 weeks. Key
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