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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05002127




Registration number
NCT05002127
Ethics application status
Date submitted
27/07/2021
Date registered
12/08/2021

Titles & IDs
Public title
A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)
Scientific title
A Phase 2/3 Study of Evorpacept (ALX148) in Patients with Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Secondary ID [1] 0 0
AT148006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Gastric Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Evorpacept (ALX148)
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Paclitaxel

Experimental: Phase 2 - Arm A - Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Active comparator: Phase 2 - Arm B - Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Experimental: Phase 3 - Arm A - Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Active comparator: Phase 3 - Arm B - Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.


Treatment: Drugs: Evorpacept (ALX148)
IV Q2W

Treatment: Drugs: Trastuzumab
IV Q2W

Treatment: Drugs: Ramucirumab
IV Q2W

Treatment: Drugs: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2
Assessment method [1] 0 0
Percentage of patients with objective response per RECIST 1.1
Timepoint [1] 0 0
Last randomized patient on study at least 16 weeks
Primary outcome [2] 0 0
Phase 3
Assessment method [2] 0 0
Overall Survival
Timepoint [2] 0 0
From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Eligibility
Key inclusion criteria
* HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)
* Adequate Bone Marrow Function.
* Adequate Renal & Liver Function.
* Adequate Performance Status
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
* Prior treatment with any anti-CD47 or anti-SIRPa agent.
* Prior treatment with ramucirumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Icon Cancer Centre Southport - Southport
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerp
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Králové
Country [9] 0 0
Czechia
State/province [9] 0 0
Olomouc
Country [10] 0 0
Czechia
State/province [10] 0 0
Prague
Country [11] 0 0
France
State/province [11] 0 0
Besançon
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Brest
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Italy
State/province [18] 0 0
Catania
Country [19] 0 0
Italy
State/province [19] 0 0
Florence
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Italy
State/province [22] 0 0
Udine
Country [23] 0 0
Japan
State/province [23] 0 0
Chiba
Country [24] 0 0
Japan
State/province [24] 0 0
Fukuoka
Country [25] 0 0
Japan
State/province [25] 0 0
Gifu
Country [26] 0 0
Japan
State/province [26] 0 0
Kumamoto
Country [27] 0 0
Japan
State/province [27] 0 0
Kyoto
Country [28] 0 0
Japan
State/province [28] 0 0
Nagasaki
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Saitama
Country [31] 0 0
Japan
State/province [31] 0 0
Sendai
Country [32] 0 0
Japan
State/province [32] 0 0
Shizuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Yokohama
Country [35] 0 0
Japan
State/province [35] 0 0
Oita
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Busan
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Daegu
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Daejeon
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Dongan
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Goyang-si
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Jeonju
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seongnam
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Suwon
Country [45] 0 0
Singapore
State/province [45] 0 0
Singapore
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Badalona
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Córdoba
Country [50] 0 0
Spain
State/province [50] 0 0
Lugo
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Santander
Country [53] 0 0
Spain
State/province [53] 0 0
Zaragoza
Country [54] 0 0
Taiwan
State/province [54] 0 0
Beitou
Country [55] 0 0
Taiwan
State/province [55] 0 0
Kaohsiung
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Tainan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ALX Oncology Inc.
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Philip Fanning, PhD
Address 0 0
Country 0 0
Phone 0 0
650-466-7125
Email 0 0
info@alxoncology.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.