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Gemcitabine

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Albumin-Bound Paclitaxel

Part A: AMP945 administered in dose escalating cohorts Part B: AMP945 recommended phase 2 dose

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 ascending doses

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

AMP945 RP2D

Trial Information

Woo Jin Lee

Jin Won Kim

Choong-kun Lee

Do-Youn Oh

Jung Yong Hong

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.

Single arm study but 2 parts;

* Part A is dose escalation
* Part B is open label single dose level

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

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

Overall response, based on RECIST, by imaging timepoint

DOR based on RECIST defined as the time from the date of the first confirmed response to the date of progression or death

OS of participants, defined as time from first dose until death from any cause

PFS of participants, defined as time from first dose to date of first observed progression, based on RECIST, or death from any cause (whichever comes first)

Time to progression, defined as time from first dosing to date of first observed progression, based on RECIST

CBR defined as complete response (CR) + partial response (PR) + stable disease

Changes in levels of tumour antigens (serum CA19-9) at the end of each treatment cycle compared to baseline

Change in levels of other relevant blood biomarkers including p-FAK, PRO-C3, PRO-C6, PRO-C11, C3M, C6M, and C4G

TEAEs during study treatment and follow up periods

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

Overall response rate based on RECIST 1.1

Measurement of maximum concentration (cmax) of AMP945

Spots Global Cancer Trial Database for amp945 ascending doses