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

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NCT06467357 · readout in 663 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

620estimated

Sites

269

Countries

Australia, Austria, Belgium +24

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-08-12

actual

When the study began enrolling

Primary completion

2028-06-12

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-05-16

estimated

The whole study's end, after follow-up

First posted

2024-06-21

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-19

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Biliary Tract Cancer

Interventions

Drug: Gemcitabine
Drug: Cisplatin
Drug: Durvalumab
Drug: Trastuzumab deruxtecan — also filed as DS-8201a; T-DXd
Drug: Rilvegostomig

Primary outcomes

what the primary-completion date above is the date OF

Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig

measured Until all patients have completed at least 1 full Cycle (each cycle is 21 days)

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

measured 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)

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