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RNA-based Therapy

ALN-BCAT + Pembrolizumab for Liver Cancer

Phase 1
Recruiting
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child-Pugh class A or B7
Has HCC confirmed histologically or cytologically, or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria
Must not have
Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
Has symptomatic extrahepatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to the end of the last study drug administration
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to determine the safe and tolerable dose of ALN-BCAT when used alone and in combination with pembrolizumab. It also seeks to identify the recommended dose for further

Who is the study for?
This trial is for patients with hepatocellular carcinoma, a type of liver cancer. Participants should meet specific health criteria set by the study's guidelines to be eligible.
What is being tested?
The trial is testing ALN-BCAT alone and in combination with Pembrolizumab. It aims to find safe dosages, understand side effects, and assess how well these treatments work against liver cancer.
What are the potential side effects?
While not specified here, common side effects for cancer treatments like ALN-BCAT and Pembrolizumab may include fatigue, nausea, immune-related reactions, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver function is mildly to moderately impaired.
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My liver cancer diagnosis is confirmed by a doctor's evaluation or tests.
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I have received treatment for cancer that cannot be surgically removed.
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My cancer has a mutation in the WNT-pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed).
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I have symptoms from cancer that has spread outside my liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to the end of the last study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to the end of the last study drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Concentrations of ALN-BCAT in Plasma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Monotherapy: Dose ExpansionExperimental Treatment1 Intervention
Patients will be administered multiple doses of ALN-BCAT.
Group II: Monotherapy: Dose EscalationExperimental Treatment1 Intervention
Patients will be administered multiple doses of ALN-BCAT.
Group III: Combination Therapy: Dose ExpansionExperimental Treatment2 Interventions
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
Group IV: Combination Therapy: Dose EscalationExperimental Treatment2 Interventions
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
79 Previous Clinical Trials
15,907 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,889 Previous Clinical Trials
8,089,035 Total Patients Enrolled
~105 spots leftby Sep 2027
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