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Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

ET140203 autologous T cell product

Pei Wang, PhD

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140203 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)

Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion

Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.

Tolerability of ET140203T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response

Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.

Assess the persistence of ET140203 T cells circulating in blood over time

Eureka Therapeutics Inc.

Antineoplastic Agents

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

D1-14 S-1 dose of level 1/2/3/4 D1-21 Sorafenib 400mg twice daily Every 3 weeks-cycle

sorafenib, TS-1

In preclinical studies, 5-fluorouracil, one of the active metabolites of S-1, showed synergistic effect to sorafenib in human colon carcinoma cell lines. Therefore, sorafenib combined with S-1 might be more effective treatment for patients with advanced HCC than sorafenib monotherapy. The investigators propose to conduct a phase I study to determine maximal tolerated dose (MTD) of S-1 in combination with fixed dose of sorafenib in patients with advanced HCC

Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma

Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma

Primary objectives:

1. To determine maximal tolerated dose (MTD) of S-1 combined with fixed dose of sorafenib 400mg twice daily.

Secondary objectives:

1. To evaluate toxicity profiles and dose-limiting toxicity (DLT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)	NCT04502082	Hepatocellular ... Liver Cancer Liver Neoplasm Metastatic Live...	ET140203 autolo...	18 Years -	Eureka Therapeutics Inc.
Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma	NCT01131689	Hepatocellular ...	sorafenib, TS-1	18 Years -	Samsung Medical Center
Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma	NCT01131689	Hepatocellular ...	sorafenib, TS-1	18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for metastatic hcc