A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT06600321
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALN-BCAT — DRUG
    Administered by intravenous (IV) infusion
  • Pembrolizumab — DRUG
    Administered by intravenous (IV) infusion

Study Details

The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.

Key Dates

Start date
Dec 30, 2024
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
158 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy: Dose Escalation
    Patients will be administered multiple doses of ALN-BCAT.
  • Experimental: Monotherapy: Dose Expansion
    Patients will be administered multiple doses of ALN-BCAT.
  • Experimental: Combination Therapy: Dose Escalation
    Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
  • Experimental: Combination Therapy: Dose Expansion
    Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.

Primary Outcome Measure

Frequency of Adverse Events (AEs) [ Time Frame: From the time of first dose of study drug administration to 30-37 days after the last dose ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Clinical Trial SitePhoenixArizona85054-
Clinical Trial SiteLa JollaCalifornia92037-
Clinical Trial SiteLos AngelesCalifornia90033-
Clinical Trial SiteJacksonvilleFlorida32224-
Clinical Trial SiteAtlantaGeorgia30322-
Clinical Trial SiteChicagoIllinois60637-
Clinical Trial SiteAnn ArborMichigan48109-
Clinical Trial SiteRochesterMinnesota55905-
Clinical Trial SiteNew YorkNew York10029-
Clinical Trial SiteNew YorkNew York10032-
Clinical Trial SiteClevelandOhio44106-
Clinical Trial SitePittsburghPennsylvania15232-
Clinical Trial SiteDallasTexas75390-
Clinical Trial SiteHoustonTexas77030-
Clinical Trial SiteSan AntonioTexas78229-
Clinical Trial SiteRichmondVirginia23298-

Find similar trials in Phoenix, AZ

By research site
Clinical Trial Site· Phoenix, AZClinical Trial Site· La Jolla, CAClinical Trial Site· Los Angeles, CAClinical Trial Site· Jacksonville, FLClinical Trial Site· Atlanta, GAClinical Trial Site· Chicago, IL

Related Studies