The purpose of the dose escalation part of the study is to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as this drug alone and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to measure the antitumor activity of ALN-BCAT as this drug alone and in combination with pembrolizumab; to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab.
Official registry: https://clinicaltrials.gov/study/NCT06600321 · Alnylam Pharmaceuticals · enrollment listed as 158
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are ALN-BCAT, or Pembrolizumab. The registry lists allocation as randomized. The purpose of the dose escalation part of the study is to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as this drug alone and in combination with pembrolizumab.
They plan to enroll about 158 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Interventions: ALN-BCAT, Pembrolizumab
Primary outcome (registry wording): Frequency of Adverse Events (AEs)
Alnylam Clinical Trial Information Line
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 6 sites outside the US on the same record
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs.
NCT02417740 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary