Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC

Plain-language summary

This study examines TCR-modified T cell therapies (ANOC-001, ANOC-002, ANOC-003) that target KRAS G12V or KRAS G12D mutations in the tumor of patients with metastatic or locally advanced pancreatic cancer (PDAC). Adults aged 18 and older with confirmed HLA genotyping and a confirmed KRAS mutation may take part. The study is being conducted in Phase 1/Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

Anocca AB

Intervention

ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)

Start date

7/3/2025

Estimated completion

7/31/2030

Countries

Denmark, Germany, Netherlands, Sweden

Related genes

Locations

• Copenhagen, Denmark
• Berlin, Germany
• Dresden, Germany
• Heidelberg, Germany
• Leipzig, Germany
• München, Germany
• Tübingen, Germany
• Amsterdam, Netherlands
• Nijmegen, Netherlands
• Stockholm, Sweden

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
2. HLA genotyping confirmed with a high-resolution method.
3. Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
4. 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, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).
5. Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
6. 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 resonance imaging (MRI) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast.

Exclusion Criteria:

1. Another malignancy other than PDAC.
2. Current or history of brain metastasis.
3. Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.