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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
Timepoint [1] 0 0
Last randomized patient on study at least 16 weeks
Primary outcome [2] 0 0
Phase 3
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
15/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
450
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
Edegem
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
Auvergne-Rhône-Alpes
Country [12] 0 0
France
State/province [12] 0 0
Bretagne
Country [13] 0 0
France
State/province [13] 0 0
Provence Alpes Cote D-Azure
Country [14] 0 0
France
State/province [14] 0 0
Besançon
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
Italy
State/province [19] 0 0
Catania
Country [20] 0 0
Italy
State/province [20] 0 0
Florence
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Italy
State/province [23] 0 0
Udine
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Fukuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Gifu
Country [27] 0 0
Japan
State/province [27] 0 0
Kumamoto
Country [28] 0 0
Japan
State/province [28] 0 0
Kyoto
Country [29] 0 0
Japan
State/province [29] 0 0
Nagasaki
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Saitama
Country [32] 0 0
Japan
State/province [32] 0 0
Sendai
Country [33] 0 0
Japan
State/province [33] 0 0
Shizuoka
Country [34] 0 0
Japan
State/province [34] 0 0
Tokyo
Country [35] 0 0
Japan
State/province [35] 0 0
Yokohama
Country [36] 0 0
Japan
State/province [36] 0 0
Oita
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Gyeonggido
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Daegu
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Daejeon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Goyang-si
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Jeonju
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seongnam
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Suwon
Country [46] 0 0
Singapore
State/province [46] 0 0
Singapore
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Zaragozza
Country [49] 0 0
Spain
State/province [49] 0 0
Alicante
Country [50] 0 0
Spain
State/province [50] 0 0
Córdoba
Country [51] 0 0
Spain
State/province [51] 0 0
Lugo
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Santander
Country [54] 0 0
Taiwan
State/province [54] 0 0
Liuying
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taipei
Country [56] 0 0
Taiwan
State/province [56] 0 0
Kaohsiung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taichung
Country [58] 0 0
Taiwan
State/province [58] 0 0
Tainan
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
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.


Results not provided in https://clinicaltrials.gov/study/NCT05002127