In short
Clinical trials are studying ANOC-001 in adults with metastatic or locally advanced pancreatic ductal adenocarcinoma. These trials aim to assess safety, tolerability, and the dose that can be given safely, as well as early signs of how well the treatment may work.
Key points
- ANOC-001 is being studied in a Phase 1/2 clinical trial for adults with metastatic or locally advanced pancreatic ductal adenocarcinoma. The main goal is to check safety and tolerability, and to find the dose that can be given safely. The trial also measures dose-limiting toxicities, adverse events, and special safety events. In phase 1, participants must match the needed HLA and KRAS mutation status for the specific TCR-T product. The study is authorised and plans to enroll 57 participants.
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. It is an interventional study, which means the research team gives the study treatment and watches what happens.
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. Phase 2 continues to assess safety and tolerability of the recommended Phase 2 dose, or RP2D.
Who can participate
The trial is for adult patients with metastatic or locally advanced PDAC. For the phase 1 part, participants must also be HLA and KRAS mutation status matched to the specific TCR-T product.
HLA means a set of markers on cells that can help determine whether a person matches a specific therapy. KRAS mutation status means whether the cancer has a change in the KRAS gene, which is part of the study’s matching rules.
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). DLTs are side effects that may limit treatment and help researchers decide whether a dose is too high.
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. Adverse events are any unwanted medical problems seen during the study, and severity means how mild or serious they are.
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.
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. AESIs are side effects the study team watches especially closely because they are important for this treatment plan.
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. 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.
The intervention listed for this trial is ANOC-001 (IV INFUSION). 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.
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. The planned enrollment is 57 participants.
Because the trial is small and early stage, its main purpose is not to prove benefit right away. 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.