Table of Contents
- Trial overview
- Who can participate
- What the trial measures
- Trial design and phase
- Study status and size
Trial overview
The trial is studying ANOC-001 in adults with metastatic or locally advanced pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer.[1] It is an interventional study, which means the research team gives the study treatment and watches what happens.[1]
The brief summary says phase 1 is designed to assess safety and tolerability of ANOC-001, ANOC-002, and ANOC-003 in participants who are matched for HLA and KRAS mutation status to the specific TCR-T product.[1] Phase 2 continues to assess safety and tolerability of the recommended Phase 2 dose, or RP2D.[1]
Who can participate
The trial is for adult patients with metastatic or locally advanced PDAC.[1] For the phase 1 part, participants must also be HLA and KRAS mutation status matched to the specific TCR-T product.[1]
HLA means a set of markers on cells that can help determine whether a person matches a specific therapy.[1] KRAS mutation status means whether the cancer has a change in the KRAS gene, which is part of the study’s matching rules.[1]
What the trial measures
The main goal in phase 1 is to study safety and tolerability, including the incidence and nature of dose-limiting toxicities (DLTs).[1] DLTs are side effects that may limit treatment and help researchers decide whether a dose is too high.[1]
The study also measures the incidence, nature, and severity of adverse events (AEs), using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.[1] Adverse events are any unwanted medical problems seen during the study, and severity means how mild or serious they are.[1]
Another phase 1 goal is to identify the maximum tolerated dose (MTD), maximum administered dose (MAD), or RP2D of ANOC-001, ANOC-002, and ANOC-003 that can be given safely in participants with metastatic or locally advanced PDAC.[1]
In phase 2, the study continues to assess safety and tolerability by tracking adverse events of special interest (AESIs), also graded with NCI-CTCAE v5.0.[1] AESIs are side effects the study team watches especially closely because they are important for this treatment plan.[1]
Trial design and phase
This is a Phase 1/2 trial, which means it starts by testing safety and dose selection and then continues into a later stage of safety assessment.[1] The study is part of a master protocol, which is a single trial plan that can include more than one related treatment or study part.[1]
The intervention listed for this trial is ANOC-001 (IV INFUSION).[1] The source data does not give more detail on dosing in this record, so the key point is that the trial is focused on testing the treatment in a controlled research setting.[1]
Study status and size
The study status is Authorised, which means it has been approved to proceed in the setting described by the source data.[1] The planned enrollment is 57 participants.[1]
Because the trial is small and early stage, its main purpose is not to prove benefit right away.[1] Instead, it is designed to learn whether ANOC-001 can be given safely, what dose range may be appropriate, and what safety issues need close attention in adults with advanced pancreatic cancer.[1]
