NCT04777708

BO-112 and Pembrolizumab for the Treatment of PD-1/PD-L1 Refractory Liver Cancer

Terminated EARLY_PHASE1 Last updated 24 March 2023

What this trial tests

EARLY_PHASE1 trial testing Nanoplexed Poly I:C BO-112 in Advanced Hepatocellular Carcinoma in 1 participant. Terminated before completion.

Timeline

13 October 2021

Primary endpoint
13 March 2023

13 March 2023

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	13 October 2021
Primary completion	13 March 2023
Estimated completion	13 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Nanoplexed Poly I:C BO-112 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →
• BCLC Stage B Hepatocellular Carcinoma — all drugs for BCLC Stage B Hepatocellular Carcinoma →
• BCLC Stage C Hepatocellular Carcinoma — all drugs for BCLC Stage C Hepatocellular Carcinoma →
• Refractory Hepatocellular Carcinoma — all drugs for Refractory Hepatocellular Carcinoma →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Advanced Hepatocellular Carcinoma or BCLC Stage B Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This early phase I trial evaluates the side effects of BO-112 and pembrolizumab and how well they work in treating patients with Barcelona Clinic Liver Cancer (BCLC) stage B or C liver cancer. Immunotherapy with BO-112, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving BO-112 and pembrolizumab may help treat patients with liver cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
2. Hepatocellular carcinoma in viral and autoimmune liver diseases: Role of CD4+ CD25+ Foxp3+ regulatory T cells in the immune microenvironment.
   Granito A, Muratori L, Lalanne C, Quarneti C, et al · · 2021 · cited 138× · PMID 34168403 · DOI 10.3748/wjg.v27.i22.2994
3. Trial watch: intratumoral immunotherapy.
   Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677
4. Targeting tumour-reprogrammed myeloid cells: the new battleground in cancer immunotherapy.
   De Sanctis F, Adamo A, Canè S, Ugel S. · · 2023 · cited 39× · PMID 36161514 · DOI 10.1007/s00281-022-00965-1
5. Tumour-associated macrophages: versatile players in the tumour microenvironment.
   Ji ZZ, Chan MK, Chan AS, Leung KT, et al · · 2023 · cited 18× · PMID 37965573 · DOI 10.3389/fcell.2023.1261749
6. The Tumor Microenvironment of Hepatocellular Carcinoma: Untying an Intricate Immunological Network.
   Volponi C, Gazzillo A, Bonavita E. · · 2022 · cited 10× · PMID 36551635 · DOI 10.3390/cancers14246151
7. Emerging advances in drug delivery systems (DDSs) for optimizing cancer complications.
   Li K, Guo B, Gu J, Ta N, et al · · 2025 · cited 8× · PMID 39759851 · DOI 10.1016/j.mtbio.2024.101375
8. Efficacy of LCMV-based cancer immunotherapies is unleashed by intratumoral injections of polyI:C.
   Gomar C, Di Trani CA, Bella A, Arrizabalaga L, et al · · 2024 · cited 4× · PMID 38631714 · DOI 10.1136/jitc-2023-008287