AZD5851 / AstraZeneca - LARVOL DELTA

ATHENA: A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=94 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Tyrosine kinase inhibitor combination therapies with AZD5851, dominant-negative TGFβRII armored anti-GPC3 CAR-T, for the treatment of hepatocellular carcinoma (AACR 2025) - P1/2 | "The multi-target tyrosine kinase inhibitors (TKIs) sorafenib and lenvatinib are licensed for first line treatment of advanced/recurrent HCC. The TKI lenvatinib enhances TGFβRII dominant-negative receptor armored GPC3 CAR-T (AZD5851) anti-tumor efficacy in vivo without affecting acute CAR-T viability, proliferation, activation, effector cytokine production, and cytotoxicity. Therefore, combining AZD5851 with lenvatinib may be a promising combination therapeutic regimen for patients with HCC."

Combination therapy • Hepatocellular Cancer • Oncology • Solid Tumor • FGFR • TGFB1

AZ, which has covered everything from immunotherapy to ADC...starts next-generation CAR-T research [Google translation] (Medipana) - "According to the relevant industry on the 2nd, AstraZeneca Korea received clinical approval from the Ministry of Food and Drug Safety for the phase 1/2 open clinical trial of its CAR-T treatment candidate AZD5851 targeting adult subjects with advanced and recurrent hepatocellular carcinoma on the 31st of last month....To this end, AstraZeneca will enroll 24 patients in phase 1 and 50 patients in phase 2 to evaluate the safety, cytodynamics, and efficacy of AZD5851. Another notable feature of this clinical trial is that it is being conducted only in Korea, excluding the United States."

New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

LOCUS: LTFU for All Cell and Gene Therapy Studies (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: AstraZeneca | Initiation date: Jun 2024 ➔ Oct 2024

Gene therapy • Trial initiation date • Gastrointestinal Cancer • Gene Therapies • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

ATHENA: A phase 1/2 study of AZD5851, a chimeric antigen receptor (CAR) T-cell therapy directed against GPC3 in adult patients with advanced/recurrent hepatocellular carcinoma (HCC). (ASCO 2024) - P1/2 | "Early clinical data with C-CAR031, a CAR-T product with the same GPC3-specific CAR and dnTGFβRII-armoring transgene as AZD5851, showed promising tolerability and antitumor activity in pts with HCC [1]. AACR 2023. Abstract CT097."

Clinical • IO biomarker • Metastases • P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

LOCUS: LTFU for All Cell and Gene Therapy Studies (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: AstraZeneca | N=30 ➔ 64 | Initiation date: Feb 2024 ➔ Jun 2024

Enrollment change • Gene therapy • Trial initiation date • Gastrointestinal Cancer • Gene Therapies • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

LOCUS: LTFU for All Cell and Gene Therapy Studies (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: AstraZeneca

Gene therapy • New trial • Gastrointestinal Cancer • Gene Therapies • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in China (PRNewswire) - "AbelZeta Pharma Inc...announced an agreement with AstraZeneca to co-develop C-CAR031, an autologous, armored GPC3-targeting chimeric antigen receptor T Cells (CAR-T) therapy, in hepatocellular carcinoma...Under the terms of the agreement, AbelZeta will receive an upfront payment from AstraZeneca for the co-development and commercialization of C-CAR031 in China. AbelZeta is also eligible to receive milestone payments and royalties for the global development of AZD5851, which is being solely developed, manufactured and commercialized by AstraZeneca outside of China. "

Licensing / partnership • Hepatocellular Cancer

ATHENA: A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

ATHENA: A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: AstraZeneca

CAR T-Cell Therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3