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

StatusRecruiting

PhasePhase 1

SponsorAlnylam Pharmaceuticals

Started2024-12-30

View on ClinicalTrials.gov ↗

Amendment history

2026-06-16

Study Status v19

Re-verified, no change to tracked fields

2026-05-28

Study Status, Contacts/Locations v18

Study sitesdetails revised at 1 of 23 sites

2026-04-29

2 amendments v16-v17

2 re-verifications since 2026-03-30, no change to tracked fields

2026-02-13

Study Status, Contacts/Locations v15

Study sitesdetails revised at 2 of 23 sites

2025-12-18

Study Status, Contacts/Locations v14

Study sites20→23

Show 13 earlier versions

2025-11-12

Study Status, Contacts/Locations v13

Study sites19→20

2025-10-15

Study Status, Contacts/Locations v12

Study sites13→19

2025-09-16

Study Status v11

Re-verified, no change to tracked fields

2025-08-25

Study Status, Contacts/Locations v10

Study sites11→13

2025-07-15

Study Status v9

Re-verified, no change to tracked fields

2025-06-16

Study Status, Contacts/Locations v8

Study sites9→11

2025-05-12

Study Status, Contacts/Locations v7

Study sites6→9

2025-04-15

Study Status, Contacts/Locations v6

Study sites5→6

2025-02-13

Study Status, Contacts/Locations v5

Study sites4→5

2025-01-23

Study Status, Contacts/Locations v4

Start dateestimated 2024-12-31→confirmed 2024-12-30

Study sites2→4

2024-12-05

Study Status v3

Start date2024-11-30→2024-12-31

2024-11-14

Study Status, Contacts/Locations v2

Start date2024-10-31→2024-11-30

Study sites1→2

2024-10-11

Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start date2024-09-18→2024-10-31

Secondary endpointsdetails revised at 1 of 3 entries

Study sitesdetails revised at 1 of 1 site

2024-09-13

Original filing

Alnylam Pharmaceuticals

31 trials monitored

See 5 trials at risk

Liver Cancer

1,505 trials monitored

See 60 trials at risk

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.

Trial Details

NCT Number	NCT06600321
Lead Sponsor	Alnylam Pharmaceuticals
Conditions	Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Enrollment	158 participants
Start Date	2024-12-30
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17