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New treatment option for PDAC
Official title Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC
ClinicalTrials.gov ID: NCT07145450
What this study is testing
What is ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)?
ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pdac.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
- HLA genotyping confirmed with a high-resolution method.
- Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
- Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS...
- Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
You likely can't join if
- Another malignancy other than PDAC.
- Current or history of brain metastasis.
- Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
See the full eligibility criteria
- Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
- HLA genotyping confirmed with a high-resolution method.
- Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
- Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants...
- Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
- Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT of chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), or magnetic...
- Another malignancy other than PDAC.
- Current or history of brain metastasis.
- Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Berlin, Germany
- Dresden, Germany
- Heidelberg, Germany
- Leipzig, Germany
- München, Germany
- Tübingen, Germany
- Amsterdam, Netherlands
- Nijmegen, Netherlands
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Berlin, Germany; Dresden, Germany; Heidelberg, Germany; Leipzig, Germany; München, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.