A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1)

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 22, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2026

Conditions
Hepatocellular Carcinoma
Interventions
BIOLOGICAL

Peptide-based hepatocellular carcinoma vaccine IMA970A

IMA970A is a lyophilized multi-peptide vaccine consisting of 17 individual peptides (active pharmaceutical ingredients) and 2 excipients (Poloxamer 338 and Mannitol). All peptides have been chemically manufactured by well established solid phase peptide synthesis procedures. All peptides are composed of linear, unmodified L- amino acid chains with chain length in the range of 9 to 21 amino acids.

COMBINATION_PRODUCT

Durvalumab

anti-PD-L1

OTHER

Montanide (Adjuvant)

Montanide ISA™ 51 is a water-in-oil (W/O) emulsion composed of a mineral oil and a surfactant from the mannide monooleate family with immune stimulatory effect .

Trial Locations (1)

80131

RECRUITING

Luigi Buonaguro, Napoli

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER