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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 31, 2022

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2026

Conditions
Pancreatic CancerPDACPancreatic Ductal Adenocarcinoma
Interventions
DRUG

AMP945 ascending doses

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.

DRUG

AMP945 RP2D

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

Trial Locations (13)

2065

GenesisCare, St Leonards

2145

Westmead Hospital, Westmead

2298

Calvary Mater Newcastle, Waratah

3021

Western Health, St Albans

3080

Seoul National University Hospital, Seoul

3121

Epworth Healthcare, Richmond

3128

Epworth Healthcare, Box Hill

3168

Monash Health, Clayton

4120

Gallipolli Medical Research Foundation, Greenslopes

6351

Samsung Medical Centre, Seoul

10408

National Cancer Centre, Gyeonggi-do

13620

Seoul National University Bundang Hospital, Gyeonggi-do

03722

Severence Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Amplia Therapeutics Limited

INDUSTRY