ANOC-001 for Pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 1. Pre-screening: Adult participants (18 years or older) with newly diagnosed metastatic PDAC or locally advanced PDAC disease.\n- 18. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): ECOG performance status of <=1 or Karnofsky performance status >=70%.\n- 19. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Renal: Creatinine clearance >=50 mL/min by chronic kidney disease epidemiology collaboration (CKD-EPI) or 24-hour urine clearance.\n- 6. Leukapheresis: Redacted\n- 20. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Hepatic: Total bilirubin <2.0 mg/dL\n- 7. Leukapheresis: Redacted\n- 8. Leukapheresis: Redacted\n- 9. Leukapheresis: Adequate venous access suitable for leukapheresis.\n- 14. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Redacted\n- 15. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Measurable disease by RECIST 1.1 criteria at the time of first line treatment. Baseline imaging (for example, diagnostic computed tomography (CT) chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), magnetic resonance imaging (MRI) or CT scan) must be obtained before the first planned T cell infusion. CT can be substituted for MRI in participants who are unable to have CT contrast.\n- 16. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Participants must be at 2-3 weeks from last systemic treatment; 2-3 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), small molecule or chemotherapy cancer treatment, other investigational agents. If a resolution of any residual toxicity of Grade <=1 occurs before 2-3 weeks, participants can start the treatment at the PI discretion.\n- 10. Leukapheresis: Fertile male and female participants must use a highly effective contraceptive method before, during, and after the last mutKRAS TCR infusion, per timelines defined in Protocol. 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, condom plus spermicide. Fertile female and male participants must adhere to any treatment-specific pregnancy prevention guidelines.\n- 17. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates are permitted.\n- 21. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <5x upper limit of normal (ULN).\n- 22. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Participants with suspected hyperbilirubinemia may be included if total bilirubin >3 mg/dl but no other evidence of hepatic dysfunction.\n- 23. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Hematologic: Absolute neutrophil count (ANC) >=1000 cells/ mm3\n- 24. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Nutrition: Albumin >=3 g/dL\n- 25. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Avoid using granulocyte-macrophage colony-stimulating factor (GM-CSF) supportive therapy within 72 hours of sample collection.\n- 11. Leukapheresis: 18 years or older at the time of enrolment.\n- 12. Leukapheresis: Capable of understanding and providing a written informed consent.\n- 13. Leukapheresis: Eastern Cooperative Oncology Group (ECOG) performance status of <=1 or Karnofsky performance status >=70% (no uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated uncontrolled pleural drainage more than once every 28 days).\n- 2. Pre-screening: Capable of understanding and willing to sign a written informed consent\n- 3. Pre-screening: Participants must be willing and able to comply with all study-related procedures and follow-up requirements.\n- 4. Leukapheresis: Diagnosis of metastatic PDAC or locally advanced PDAC.\n- 5. Leukapheresis: Confirmation of PDAC diagnosis."}

Exclusion criteria

• {"criterion_text":"- 1. Another malignancy other than PDAC. Participants with concomitant second malignancies (except adequately treated no melanomatous skin cancers, carcinoma in situ of the breast, treated superficial bladder cancer or prostate cancer, or in situ cervical cancers) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period. Long-term adjuvant therapy example: breast cancer is acceptable.\n- 4. Current or history of brain metastasis.\n- 5. Currently receiving other investigational medicinal products\n- 6. Participants with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.\n- 7. Women who are pregnant or breastfeeding.\n- 8. Participants with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease [SCID] or human immunodeficiency virus (HIV).\n- 9. Participants with active systemic infections, coagulation disorders, or any other major medical illnesses e.g. Hepatitis B or C.\n- 16. Current or past employees, or any of their immediate family members (spouse, parent, child, sibling) or members of their household, of the Sponsor, Contract Research Organization (CRO) or Clinical Trial Site who were/are directly involved in the study design, conduct, or analysis.\n- 10. Participants with concurrent opportunistic infections.\n- 11. Participants on concurrent systemic steroid therapy.\n- 12. Participants with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine).\n- 13. Participants with active coronary ischaemic symptoms.\n- 14. Redacted\n- 15. Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials e.g., participant reported outcomes (PRO) methods studies, are allowed.\n- 2. Redacted\n- 3. Resectable PDAC disease"}

Primary endpoints

• {"endpoint_text":"- Phase 1 Safety and tolerability: Incidence and nature of DLTs of ANOC- 001, ANOC-002 and ANOC-003, graded according to American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria.","definition_or_measurement_approach":"DLTs graded according to ASTCT consensus criteria (incidence and nature recorded)."}
• {"endpoint_text":"- Phase 1 Safety and tolerability: Incidence, nature, and severity of adverse events (AEs) graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI- CTCAE) v5.0.","definition_or_measurement_approach":"AEs graded according to NCI-CTCAE v5.0; incidence, nature and severity recorded."}
• {"endpoint_text":"- Phase 1 Safety and tolerability: Identification of the MTD/MAD or RP2D of ANOC-001, ANOC-002 and ANOC- 003 that can be administered safely in participants with metastatic and locally advanced PDAC.","definition_or_measurement_approach":"Identification of MTD/MAD or Recommended Phase 2 Dose (RP2D) based on observed safety/toxicity (dose-escalation rules not detailed in the provided text)."}
• {"endpoint_text":"- Phase 2 Safety and tolerability: Incidence, nature, and severity of adverse events of special interest (AESIs) according to NCI-CTCAE v5.0","definition_or_measurement_approach":"AESIs graded according to NCI-CTCAE v5.0; incidence, nature and severity recorded."}

Secondary endpoints

• {"endpoint_text":"- Phase 1 and Phase 2 Feasibility: Percentage of participants who receive planned target dose of ANOC-001, ANOC-002 or ANOC-003","definition_or_measurement_approach":"Percentage of participants who receive the planned target dose (numerator/denominator as percentage)."}
• {"endpoint_text":"- Phase 1 and Phase 2 Expansion/persistence: Maximum persistence of TCR T cells as peak cell expansion at different time intervals to detect infused cells.","definition_or_measurement_approach":"Peak cell expansion at defined time intervals to detect infused genetically modified T cells; maximum persistence measured as peak expansion."}
• {"endpoint_text":"- Phase 1 and Phase 2 Efficacy: Objective Response Rate (ORR) as defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1. participants.","definition_or_measurement_approach":"ORR measured per RECIST v1.1 as % of participants with BOR of CR or PR."}
• {"endpoint_text":"- Phase 1 and Phase 2 Efficacy: CBR defined as percentage of participants with SD more than 3 months, or PR/CR from the time of study treatment.","definition_or_measurement_approach":"Clinical benefit rate (CBR) defined as % participants with stable disease >3 months or PR/CR from treatment."}
• {"endpoint_text":"- Phase 1 and Phase 2 Efficacy: Progression-free survival (PFS), defined as the time from study treatment to the first occurrence of disease progression or death, whichever occurs first.","definition_or_measurement_approach":"PFS defined as time from study treatment to first disease progression or death."}
• {"endpoint_text":"- Phase 1 and Phase 2 Efficacy: Overall survival (OS) defined as the time from study treatment to death from any cause.","definition_or_measurement_approach":"OS defined as time from study treatment to death from any cause."}
• {"endpoint_text":"- Phase 1 and Phase 2 Efficacy: Duration of response (DoR) defined as the time from the first documentation of a tumour response (PR/CR) to disease progression or death in participants who achieve CR or PR.","definition_or_measurement_approach":"DoR defined as time from first documentation of PR/CR to disease progression or death in responders."}
• {"endpoint_text":"- Phase 1 and Phase 2 Feasibility: Feasibility of manufacture of ANOC-001, ANOC-002 and ANOC-003 including the percentage of the manufactured IMPs that comply with the specifications as compared to the total number of the IMP manufactured.","definition_or_measurement_approach":"Feasibility measured as percentage of manufactured IMPs that meet specifications versus total manufactured."}

Sweden

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

433

Number Of Sites

1

Number Of Participants

4

Netherlands

Earliest CTIS Part Ii Submission Date

24-01-2025

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

430

Number Of Sites

2

Number Of Participants

24

Germany

Earliest CTIS Part Ii Submission Date

12-12-2024

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

476

Number Of Sites

6

Number Of Participants

24

Denmark

Earliest CTIS Part Ii Submission Date

22-01-2025

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

432

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

Anocca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Allucent (NL) B.V.

Responsibilities

CRO services

Third parties

• {"country":"Netherlands","full_name":"Allucent (NL) B.V.","duties_or_roles":"CRO services","organisation_type":"Pharmaceutical company"}