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RecruitingLast updated: 1 December 2023

ACCENT: This phase study is trying to determine the effectiveness of administering a targeted therapy (AMP945), prior to chemotherapy (gemcitabine and nab-paclitaxel), in people with pancreatic cancerA Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients

Clinical summary

Summary

This study has two parts. In Part A (dose escalation), eligible participants will be allocated to one of 4 dose-level cohorts to determine the recommended dose of AMP945. In Part B, participants will receive AMP945 at the dose level determined in Part A.

Conditions

This trial is treating patients with pancreatic cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

I/II

Trial Acronym

ACCENT

More information

Trial Identifiers

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Trial sponsor

Amplia Therapeutics Limited

Scientific Title

A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination With Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients

Eligibility

Inclusion

  1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
  2. Aged at least 18 years at the time of consent.
  3. Confirmed histological or cytological diagnosis of advanced pancreatic adenocarcinoma that is:

    Part A: metastatic or not surgically resectable.

    Part B: metastatic, with initial diagnosis of metastatic disease ≤6 weeks prior to Baseline.

  4. Has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  5. Eligible for treatment with nab-paclitaxel and gemcitabine as standard of care therapy.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1, sustained on two separate assessments: the first at least 2 weeks prior to the 1st dose of AMP945 and the 2nd within 72 hours prior to the 1st dose of AMP945. Participants not maintaining an ECOG Performance Score of 0-1 at the second assessment will be excluded from participation.
  7. Has a life expectancy of >3 months.
  8. Adequate organ function, as defined by the laboratory results below (samples must be obtained ≤14 days prior to study drug administration):

    a) Haematology:

    (i) Absolute neutrophil count (ANC) ≥1.5 × 109/L;

    (ii) Platelet count ≥100,000/mm3 (100 × 109/L);

    (iii) Haemoglobin (Hgb) ≥9 g/dL.

    b) Serum chemistry:

    (i) Aspartate transaminase (AST) (SGOT), ALT (SGPT) ≤2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤5 × ULN is allowed;

    (ii) Total bilirubin ≤ULN;

    (iii) Creatinine <1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) >60 mL/min/1.73m2 (calculated using the Cockcroft-Gault equation).

    c) No clinically significant abnormalities in coagulation results.

    d) No clinically significant abnormalities in urinalysis results.

  9. Agree to use contraception according to protocol

Exclusion

  1. Pregnant or breast-feeding, or plans to become pregnant during the study.
  2. Has received any investigational medicinal product (IMP) within 30 days or 5 half-lives (whichever is longer) prior to Day -8.
  3. Known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no oedema, no steroids and stable in 2 scans at least 4 weeks apart).
  4. Gastrointestinal condition that could interfere with the swallowing or absorption of study medication.
  5. Part A: Has received prior systemic treatments for pancreatic cancer, except those given in the adjuvant setting, and with recurrence more than 6 months after completion of curative/adjuvant treatment.
  6. Part B: Has received no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study.
  7. History of malignancy other than in situ cancer or basal or squamous cell skin cancer in the last 5 years.
  8. Major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day -8.
  9. Known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections or known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
  10. Known history of myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 6 months prior to the first dose of study drug.
  11. Focal palliative radiotherapy (e.g., to a bony metastasis) within the 14 days prior to Run-in, or more extensive radiotherapy within 28 days prior to Run-in.
  12. History of chronic leukemias (e.g., chronic lymphocytic leukemia).
  13. History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
  14. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
  15. Clinical signs of active infection and/or a temperature of > 38.0°C at the time of Screening or Baseline. Study entry may be deferred at the discretion of the Principal Investigator (PI).
  16. Currently using warfarin.
  17. Administration of a live virus vaccine in the 4 weeks prior to Day -8 or plans to receive a live virus vaccine during the study.
  18. Clinically significant allergies to AMP945, nab-paclitaxel or gemcitabine (or any of their excipients), including hypersensitivity reactions to human albumin, that are not likely to be well controlled with premedication or other supportive measures.
  19. Exhibiting any of the conditions or events outlined in the Contraindications or Special Warnings and Precautions sections of the nab-paclitaxel and/or gemcitabine package inserts.
  20. Peripheral neuropathy > Grade 1.
  21. Corrected QT interval using Fridericia's correction (QTcF) > 460 ms for males and >480 ms for females.
  22. Any clinically relevant medical, social, or psychiatric conditions, or any finding during Screening, which in the Investigator's opinion may put the participant at unacceptable risk or interfere with the study objectives.
  23. Prior treatment with AMP945.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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