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T-DXd + Rilvegostomig for Biliary Tract Cancer (DESTINY-BTC01 Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential

Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations

Must not have

Prior pneumonectomy (complete)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until end of study (estimated up to 48 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare the effectiveness and safety of a new drug combination called T-DXd with rilvegostomig or T-DXd alone to the standard treatment of gemcitabine

Who is the study for?

This trial is for adults with advanced HER2-expressing Biliary Tract Cancer (BTC) who haven't had treatment before. Participants must have a specific protein in their cancer cells, which will be checked using special tests like Ventana PD-L1 SP263 assay or Agilent HercepTest™ mAb pharmDx.

What is being tested?

The study compares the effectiveness and safety of T-DXd alone or combined with rilvegostomig against standard chemotherapy (gemcitabine plus cisplatin) and durvalumab. It's a Phase 3 trial, meaning it's testing treatments that have shown promise in earlier trials.

What are the potential side effects?

Possible side effects include reactions to infusion, fatigue, nausea, hair loss from chemotherapy drugs gemcitabine and cisplatin; immune-related issues from durvalumab; and potential unique effects from T-DXd and rilvegostomig.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am post-menopausal or not pregnant.

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I am 18 years old or older.

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My bile duct cancer tests positive for high levels of HER2.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a lung removed.

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I have not had a heart attack or serious heart issues in the last 6 months.

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I have an autoimmune or inflammatory condition that needed treatment in the last 2 years.

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I have been treated with drugs targeting HER2, immune therapies, or cancer vaccines before.

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My cancer is confirmed to be ampullary carcinoma.

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I do not have an infection needing IV drugs to treat.

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I do not have an active immune disorder, uncontrolled HIV, or hepatitis C.

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I do not have chronic diarrhea or serious skin conditions needing systemic treatment.

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I have or might have lung inflammation not caused by an infection.

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I do not have active brain metastases requiring steroids or seizure meds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until end of study (estimated up to 48 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until end of study (estimated up to 48 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of study (estimated up to 48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the HER2 IHC 3+ population

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

Secondary study objectives

To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum

To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care

To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care

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