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New drug combo takes on tough liver cancer

NCT ID NCT06600321

Disease control Sponsor: Alnylam Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called ALN-BCAT, given alone or with the immunotherapy Keytruda, in people with advanced or metastatic liver cancer that has a specific genetic mutation (WNT pathway). The trial aims to find safe doses and see if the drugs shrink tumors. About 158 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALN-BCAT (a drug given by IV) and pembrolizumab (Keytruda, an immunotherapy drug given by IV)
What this could lead to
If it works, this could point toward a new treatment option for advanced liver cancer that has not responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial focused on safety and dosing, so it may not show strong anti-tumor effects. Side effects from the drugs are possible, and the combination may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 158 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria * Has had at least one line of systemic therapy for unresectable advanced or metastatic disease * Has at least one wingless-related integration site (WNT)-pathway activating mutation * Child-Pugh class A or B7 Exclusion Criteria: * Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors * Has symptomatic extrahepatic disease * Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug Note: other protocol defined inclusion / exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver disorder Liver Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced hepatocellular carcinoma Metastatic hepatocellular carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Trial Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Clinical Trial Site

    RECRUITING

    La Jolla, California, 92037, United States

  • Clinical Trial Site

    RECRUITING

    Los Angeles, California, 90033, United States

  • Clinical Trial Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Clinical Trial Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Clinical Trial Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Clinical Trial Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Clinical Trial Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Clinical Trial Site

    RECRUITING

    New York, New York, 10029, United States

  • Clinical Trial Site

    COMPLETED

    New York, New York, 10032, United States

  • Clinical Trial Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Clinical Trial Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Clinical Trial Site

    RECRUITING

    Dallas, Texas, 75390, United States

  • Clinical Trial Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Clinical Trial Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Clinical Trial Site

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Clinical Trial Site

    RECRUITING

    Milan, 20132, Italy

  • Clinical Trial Site

    RECRUITING

    Rozzano, 20089, Italy

  • Clinical Trial Site

    RECRUITING

    Verona, 37134, Italy

  • Clinical Trial Site

    RECRUITING

    Busan, 49241, South Korea

  • Clinical Trial Site

    RECRUITING

    Seongnam, 13496, South Korea

  • Clinical Trial Site

    RECRUITING

    Seongnam, 13620, South Korea

  • Clinical Trial Site

    RECRUITING

    Seoul, 03722, South Korea

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