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RecruitingNCT06467357DESTINY-BTC01Updated Oct 13, 2026

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

A Phase 3 interventional study of Gemcitabine and Cisplatin in Biliary Tract Cancer, sponsored by AstraZeneca. Recruiting at 272 sites in 27 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Updated Oct 13, 2026Site recruiting status changedEligibility revised+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
620
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Biliary Tract Cancer

Keywords

  • Biliary Tract Cancer
  • HER2
  • HER2 expressing BTC
  • Trastuzumab deruxtecan
  • T-DXd
  • Rilvegostomig
03

In context

Biliary Tract Neoplasms

519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.

This study's planned enrollment of 620 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 13, 2026. See what changed

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Male and female patients must be at least 18 years of age at the time of signing the . Other age restrictions may apply as per local regulations.
  • Unresectable, previously untreated, locally advanced or biliary tract adenocarcinoma. Prior treatment in the perioperative and/or setting is permissible provided there is > 3 months (90 days) between the end of adjuvant treatment (or surgery or radiation with curative intent) and the diagnosis of locally advanced or metastatic disease.
  • confirmed -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 v1.1. (Randomized portion only)
  • performance status 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 status or negative serum pregnancy test for females of .
  • Minimum of 12 weeks.

Key Exclusion Criteria:

  • Prior exposure to other HER2 targeting therapies, ADCs, and therapeutic anticancer vaccines.
  • Histologically confirmed ampullary carcinoma.
  • Any other medical conditions such as 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 or anticonvulsants to control associated symptoms.
  • Medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure ( Class II to IV), unstable angina pectoris, cardiomyopathy of any etiology, history of myocarditis, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke.
  • Active , 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.
  • interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead .
  • History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe , restrictive lung disease, pleural effusion etc).
  • Prior pneumonectomy (complete).
  • Active primary immunodeficiency and/or active uncontrolled infectious disease(s).
  • History of another primary except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.
  • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).
  • Any concurrent anticancer treatment without an adequate prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.
  • History of organ transplants or allogenic stem cell transplant.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
620 participants (estimated)

Study arms

  • Experimental
    Trastuzumab deruxtecan + rilvegostomig

    Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm

    Drug: Trastuzumab deruxtecan · Drug: Rilvegostomig

  • Experimental
    Trastuzumab deruxtecan

    Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

    Drug: Trastuzumab deruxtecan

  • Active comparator
    Standard of Care

    Gemcitabine and cisplatin in combination with durvalumab arm

    Drug: Gemcitabine · Drug: Cisplatin · Drug: Durvalumab

Interventions

  • DrugGemcitabine

    Standard of care chemotherapy by intravenous infusion

  • DrugCisplatin

    Standard of care chemotherapy by intravenous infusion

  • DrugDurvalumab

    Standard of care immunotherapy by intravenous infusion

  • DrugTrastuzumab deruxtecan

    Experimental therapy by intravenous infusion

    Also known as: DS-8201a; T-DXd

  • DrugRilvegostomig

    Experimental therapy by intravenous infusion

06

What researchers measure

Primary outcomes

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

    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.

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

  2. 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

    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.

    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)

Secondary outcomes

  1. To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population

    Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.

    Time frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

  2. To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population

    Overall Survival (OS) in FAS (HER2 IHC 3+) population. OS definition as above.

    Time frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

  3. To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population

    Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.

    Time frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

  4. To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  5. To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  6. To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  7. To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  8. To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.

    Time frame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)

  9. To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.

    Time frame: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)

  10. To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.

    Overall survival (OS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. 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.

    Time frame: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

  11. To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS.

    Time frame: From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)

  12. To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR.

    Time frame: From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)

  13. To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations

    Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

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

    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.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

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

    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.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  16. To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs

    Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).

    Time frame: Until End of Study (estimated up to 50 months)

  17. To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs

    Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322)

    Time frame: Until End of Study (estimated up to 50 months)

  18. To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs

    Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).

    Time frame: Until End of Study (estimated up to 50 months)

  19. To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care

    Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. \- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.

    Time frame: Until End of Study (estimated up to 50 months)

  20. To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care

    Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. \- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.

    Time frame: Until End of Study (estimated up to 50 months)

  21. To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy

    Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. \- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.

    Time frame: Until End of Study (estimated up to 50 months)

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

    Descriptive analysis of serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in all applicable arms.

    Time frame: From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig

  23. To investigate the immunogenicity of T-DXd and of rilvegostomig

    Descriptive summary of presence of ADAs for T-DXd and rilvegostomig in all applicable arms.

    Time frame: From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively

  24. To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother

    Patient-reported tolerability will be described using the Overall side-effect bother that will be mesured using PGI-TT

    Time frame: Until End of Study (estimated up to 50 months)

  25. To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother

    Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT

    Time frame: Until End of Study (estimated up to 50 months)

  26. To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy

    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.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)

  27. To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother

    Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT.

    Time frame: Until End of Study (estimated up to 50 months)

07

Study locations

232 of 272 sites recruiting
  • Research Site
    Scottsdale, Arizona 85259, United States
    Recruiting
  • Research Site
    Tucson, Arizona 85704, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Tucson, Arizona 85719, United States
    Recruiting
  • Research Site
    Fullerton, California 92835, United States
    Recruiting
  • Research Site
    La Jolla, California 92093, United States
    Recruiting
  • Research Site
    Los Alamitos, California 90720, United States
    Suspended

    Not enrolling at this site — choose another above.

  • Research Site
    Los Angeles, California 90017, United States
    Recruiting
  • Research Site
    Los Angeles, California 90089, United States
    Recruiting
  • Research Site
    San Francisco, California 94143, United States
    Recruiting
  • Research Site
    Walnut Creek, California 94598, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Washington D.C., District of Columbia 20007, United States
    Not yet recruiting
  • Research Site
    Washington D.C., District of Columbia 20010, United States
    Not yet recruiting
  • Research Site
    Fort Myers, Florida 33901, United States
    Recruiting
  • Research Site
    Jacksonville, Florida 32224, United States
    Recruiting
  • Research Site
    St. Petersburg, Florida 33705, United States
    Recruiting
  • Research Site
    Tampa, Florida 33606, United States
    Suspended

    Not enrolling at this site — choose another above.

  • Research Site
    West Palm Beach, Florida 33401, United States
    Recruiting
  • Research Site
    Atlanta, Georgia 30309, United States
    Recruiting
  • Research Site
    Coeur d'Alene, Idaho 83814, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Chicago, Illinois 60612, United States
    Recruiting
  • Research Site
    Niles, Illinois 60714, United States
    Recruiting
  • Research Site
    Towson, Maryland 21204, United States
    Recruiting
  • Research Site
    Boston, Massachusetts 02215, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Worcester, Massachusetts 01655, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Detroit, Michigan 48202, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Grand Rapids, Michigan 49503, United States
    Recruiting
  • Research Site
    Rochester, Minnesota 55905, United States
    Recruiting
  • Research Site
    Kansas City, Missouri 64111, United States
    Recruiting
  • Research Site
    Kansas City, Missouri 64132, United States
    Recruiting
  • Research Site
    St Louis, Missouri 63110, United States
    Recruiting
  • Research Site
    Albuquerque, New Mexico 87102, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    New York, New York 10032, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    White Plains, New York 10601, United States
    Recruiting
  • Research Site
    Cleveland, Ohio 44111, United States
    Suspended

    Not enrolling at this site — choose another above.

  • Research Site
    Cleveland, Ohio 44124, United States
    Recruiting
  • Research Site
    Cleveland, Ohio 44195, United States
    Recruiting
  • Research Site
    Columbus, Ohio 43210, United States
    Recruiting
  • Research Site
    Pittsburgh, Pennsylvania 15232, United States
    Not yet recruiting
  • Research Site
    Greenville, South Carolina 29605, United States
    Recruiting
  • Research Site
    Nashville, Tennessee 37203, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Austin, Texas 78705, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Dallas, Texas 75246, United States
    Recruiting
  • Research Site
    Fort Worth, Texas 76104, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Fort Worth, Texas 76104, United States
    Recruiting
  • Research Site
    Houston, Texas 77030, United States
    Recruiting
  • Research Site
    Pearland, Texas 77584, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    San Antonio, Texas 78217, United States
    Withdrawn

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  • Research Site
    San Antonio, Texas 78258, United States
    Withdrawn

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  • Research Site
    Fairfax, Virginia 22031, United States
    Recruiting
  • Research Site
    Fairfax, Virginia 22031, United States
    Withdrawn

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  • Research Site
    Chermside, 4032, Australia
    Recruiting
  • Research Site
    Clayton, 3168, Australia
    Recruiting
  • Research Site
    Concord, 2139, Australia
    Recruiting
  • Research Site
    Nedlands, 6009, Australia
    Recruiting
  • Research Site
    Graz, 8036, Austria
    Recruiting
  • Research Site
    Linz, 4010, Austria
    Recruiting
  • Research Site
    Salzburg, 5020, Austria
    Recruiting
  • Research Site
    Vienna, 1090, Austria
    Recruiting
  • Research Site
    Wiener Neustadt, 2700, Austria
    Not yet recruiting
  • Research Site
    Anderlecht, 1070, Belgium
    Recruiting
  • Research Site
    Edegem, 2650, Belgium
    Recruiting
  • Research Site
    Ghent, 9000, Belgium
    Recruiting
  • Research Site
    Leuven, 3000, Belgium
    Recruiting
  • Research Site
    Liège, 4000, Belgium
    Recruiting
  • Research Site
    Roeselare, 8800, Belgium
    Recruiting
  • Research Site
    Natal, 59012-300, Brazil
    Recruiting
  • Research Site
    Porto Alegre, 90035-000, Brazil
    Recruiting
  • Research Site
    Porto Alegre, 91350-200, Brazil
    Recruiting
  • Research Site
    Santa Maria, 97015-450, Brazil
    Recruiting
  • Research Site
    São Paulo, 01246-000, Brazil
    Recruiting
  • Research Site
    São Paulo, 05651-901, Brazil
    Recruiting
  • Research Site
    Vitória, 29043-272, Brazil
    Recruiting
  • Research Site
    Edmonton, Alberta T6G 1Z2, Canada
    Recruiting
  • Research Site
    Halifax, Nova Scotia B3H 1V7, Canada
    Recruiting
  • Research Site
    Brampton, Ontario L6R 3J7, Canada
    Recruiting
  • Research Site
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
  • Research Site
    Montreal, Quebec H3A 1A1, Canada
    Recruiting
  • Research Site
    Beijing, 100020, China
    Recruiting
  • Research Site
    Beijing, 100021, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Beijing, 100034, China
    Recruiting
  • Research Site
    Beijing, 100142, China
    Recruiting
  • Research Site
    Beijing, China
    Recruiting
  • Research Site
    Bengbu, 233004, China
    Recruiting
  • Research Site
    Changchun, 130021, China
    Recruiting
  • Research Site
    Changde, 415000, China
    Recruiting
  • Research Site
    Changsha, 410005, China
    Recruiting
  • Research Site
    Changsha, 410013, China
    Recruiting
  • Research Site
    Chengdu, 610041, China
    Recruiting
  • Research Site
    Chengdu, 610078, China
    Recruiting
  • Research Site
    Chongqing, 400030, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Fuzhou, 350007, China
    Recruiting
  • Research Site
    Guangzhou, 510080, China
    Recruiting
  • Research Site
    Guangzhou, 510515, China
    Recruiting
  • Research Site
    Guiyang, 550044, China
    Recruiting
  • Research Site
    Hangzhou, 310016, China
    Recruiting
  • Research Site
    Harbin, 150081, China
    Terminated

    Not enrolling at this site — choose another above.

  • Research Site
    Hefei, 230001, China
    Recruiting
  • Research Site
    Hefei, 230601, China
    Recruiting
  • Research Site
    Jinan, 250117, China
    Recruiting
  • Research Site
    Kunming, 650101, China
    Recruiting

Showing the first 100 of 272 sites across 27 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2024 (actual). Primary completion is estimated for Jun 2028, 46 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2024
First posted
Jun 21, 2024
StartActual
Aug 12, 2024
Primary completionEst.
Jun 12, 2028
CompletionEst.
May 16, 2029
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
4 sites added, 1 site removed. 7 sites changed recruiting status (4 now recruiting, 2 now withdrawn, …)
Show 7 sites
  • Research Site · Walnut Creek, United StatesNot yet recruiting→Withdrawn
  • Research Site · Tampa, United StatesNot yet recruiting→Suspended
  • Research Site · Cleveland, United StatesSuspended→Recruiting
  • Research Site · Salzburg, AustriaNot yet recruiting→Recruiting
  • Research Site · Kanpur, IndiaRecruiting→Withdrawn
  • Research Site · Cebu City, PhilippinesNot yet recruiting→Recruiting
  • Research Site · Banská Bystrica, SlovakiaNot yet recruiting→Recruiting
Show 4 added (2 United States, 1 Japan, 1 Vietnam)
  • Research Site · Washington D.C., United States
  • Research Site · Kansas City, United States
  • Research Site · Kurashiki-shi, Japan
  • Research Site · Da Nang, Vietnam
Show 1 removed
  • Research Site · Shatin, Hong Kong
Oct 13, 2026
Eligibility
3 criteria edited, 1 added, 3 removed
What changed in the criteria
  • EditedUnresectable, 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 (or surgery or radiation with curative intent) and the diagnosis of locally advanced or metastatic disease.
  • EditedPatients 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.
  • EditedMedical 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, cardiomyopathy of any etiology, history of myocarditis, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
  • RemovedSerious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
  • RemovedUncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis/biliary tract infections/biliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.
  • RemovedActive primary immunodeficiency, known uncontrolled active HIV infection or HCV.
  • AddedActive primary immunodeficiency and/or active uncontrolled infectious disease(s).
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    4 sites added, 1 site removed. 7 sites changed recruiting status (4 now recruiting, 2 now withdrawn, …)
    Show 7 sites
    • Research Site · Walnut Creek, United StatesNot yet recruiting→Withdrawn
    • Research Site · Tampa, United StatesNot yet recruiting→Suspended
    • Research Site · Cleveland, United StatesSuspended→Recruiting
    • Research Site · Salzburg, AustriaNot yet recruiting→Recruiting
    • Research Site · Kanpur, IndiaRecruiting→Withdrawn
    • Research Site · Cebu City, PhilippinesNot yet recruiting→Recruiting
    • Research Site · Banská Bystrica, SlovakiaNot yet recruiting→Recruiting
    Show 4 added (2 United States, 1 Japan, 1 Vietnam)
    • Research Site · Washington D.C., United States
    • Research Site · Kansas City, United States
    • Research Site · Kurashiki-shi, Japan
    • Research Site · Da Nang, Vietnam
    Show 1 removed
    • Research Site · Shatin, Hong Kong
    Eligibility 3 criteria edited, 1 added, 3 removed
    What changed in the criteria
    • EditedUnresectable, 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 (or surgery or radiation with curative intent) and the diagnosis of locally advanced or metastatic disease.
    • EditedPatients 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.
    • EditedMedical 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, cardiomyopathy of any etiology, history of myocarditis, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
    • RemovedSerious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
    • RemovedUncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis/biliary tract infections/biliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.
    • RemovedActive primary immunodeficiency, known uncontrolled active HIV infection or HCV.
    • AddedActive primary immunodeficiency and/or active uncontrolled infectious disease(s).
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06467357
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Aug 12, 2024
Primary completion
Jun 12, 2028 (estimated)
Completion
May 16, 2029 (estimated)
Last update
Oct 13, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Trastuzumab deruxtecan · Rilvegostomig

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