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Pancreatic CancerPhase 1/2NCT05355298

ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer

A Phase 1/2 study testing AMP945 ascending doses and AMP945 RP2D in people with Pancreatic Cancer and PDAC, run by Amplia Therapeutics Limited at 13 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicentre, open label, two-part study to determine whether the focal adhesion kinase (FAK) inhibitor AMP945, when given prior to dosing with gemcitabine and nab-paclitaxel, improves response to therapy in first-line patients with unresectable or metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMP945 ascending doses and AMP945 RP2D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
13 sitesin 2 countries
Study dates
31 May 2022to 1 Feb 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
  • Aged at least 18 years at the time of consent.
  • 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.
  • 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.
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  • Eligible for treatment with nab-paclitaxel and gemcitabine as standard of care therapy.
  • 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.
  • Has a life expectancy of >3 months.
  • Adequate organ function, as defined by the laboratory results below (samples must be obtained ≤14 days prior to study drug administration):
  • Haematology:
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L;
  • Platelet count ≥100,000/mm3 (100 × 109/L);
  • Haemoglobin (Hgb) ≥9 g/dL.
  • Serum chemistry:
  • 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;
  • Total bilirubin ≤ULN;
  • 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).
  • No clinically significant abnormalities in coagulation results.
  • No clinically significant abnormalities in urinalysis results.
  • Agree to use contraception according to protocol

Who cannot join

  • Pregnant or breast-feeding, or plans to become pregnant during the study.
  • Has received any investigational medicinal product (IMP) within 30 days or 5 half-lives (whichever is longer) prior to Day -8.
  • 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).
  • Gastrointestinal condition that could interfere with the swallowing or absorption of study medication.
  • 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.
  • 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.
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  • History of malignancy other than in situ cancer or basal or squamous cell skin cancer in the last 5 years.
  • 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.
  • 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.
  • Known history of myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 6 months prior to the first dose of study drug.
  • 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.
  • History of chronic leukemias (e.g., chronic lymphocytic leukemia).
  • History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
  • History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
  • 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).
  • Currently using warfarin.
  • 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.
  • 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.
  • 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.
  • Peripheral neuropathy > Grade 1.
  • Corrected QT interval using Fridericia's correction (QTcF) > 460 ms for males and >480 ms for females.
  • 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.
  • Prior treatment with AMP945.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Australia8 sites

  • Epworth Healthcare

    Box Hill, Victoria, 3128

  • Monash Health

    Clayton, Victoria, 3168

  • Gallipolli Medical Research Foundation

    Greenslopes, Queensland, 4120

  • Epworth Healthcare

    Richmond, Victoria, 3121

  • Western Health

    St Albans, Victoria, 3021

  • GenesisCare

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea5 sites

  • National Cancer Centre

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Severence Hospital

    Seoul, 03722

  • Seoul National University Hospital

    Seoul, 3080

  • Samsung Medical Centre

    Seoul, 6351

Other trials in South Korea

About this study

Official 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

This is a multicentre, open label, two-part study to determine whether the focal adhesion kinase (FAK) inhibitor AMP945, when given prior to dosing with gemcitabine and nab-paclitaxel, improves response to therapy in first-line patients with unresectable or metastatic pancreatic cancer.

Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B.

Part B will determine the efficacy of the AMP945 regimen at the RP2D, and will be run as a Simon Two-stage design; Stage 1 will enrol 26 participants. If ≤5 of the 26 participants show an objective response, then recruitment will be paused and a detailed analysis of futility will be performed. If the study is deemed futile, recruitment will cease. If the study is determined to be not futile or >5 of the 26 participants show an objective response, recruitment will continue, and an additional 24 participants will be enrolled in Stage 2.

Being tested
AMP945 ascending doses, AMP945 RP2D
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMP945 ascending dosesDrug

    Part A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts, to determine the RP2D of AMP945 to be explored in Part B. Dose escalation decisions will be made using a standard 3+3 dose-escalation phase 1 oncology study design.

  • AMP945 RP2DDrug

    Part B will determine the efficacy of the AMP945 priming regimen at the recommended phase 2 dose (RP2D) determined in Part A.

Study groups in NCT05355298
Study groupRoleWhat they receive
AMP945ExperimentalPart A: AMP945 administered in dose escalating cohorts Part B: AMP945 recommended phase 2 dose
Receives: Drug: AMP945 ascending doses; Drug: AMP945 RP2D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study

    TEAEs during study treatment and follow up periods

    Measured: From first dose of study drug to end of study, an expected average of 6 months

  2. Part A: Determination of RP2D

    The RP2D of AMP945 will be determined based on either the maximum tolerated dose or maximum pharmacodynamic effect, which ever is reached first

    Measured: After Cycle 1 (28 days) for each Part A cohort

  3. Part B: efficacy of AMP945

    Overall response rate based on RECIST 1.1

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

Secondary outcomes (4)

  1. Part A: efficacy of AMP945

    Overall response rate based on RECIST 1.1

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  2. AMP945 levels in plasma

    Measurement of maximum concentration (cmax) of AMP945

    Measured: Days -8, -7, 1, 3, 4, 8 and 10

  3. AMP945 levels in plasma

    Measurement of time to cmax (tmax)

    Measured: Days -8, -7, 1, 3, 4, 8 and 10

  4. AMP945 levels in plasma

    Measurement of clearance (CL)

    Measured: Days -8, -7, 1, 3, 4, 8 and 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start31 May 2022
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study but 2 parts; * Part A is dose escalation * Part B is open label single dose level
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05355298
Sponsor's protocol ID
AMP945-PC-201
Status last verified
Jul 2026
First submitted
7 Apr 2022
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMP945 ascending doses and AMP945 RP2D in people with Pancreatic Cancer and PDAC, run by Amplia Therapeutics Limited at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study (time frame: From first dose of study drug to end of study, an expected average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05355298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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