A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

• ClinicalTrials.gov Identifier: NCT05002127
• Recruitment Status: Recruiting
• First Posted: August 12, 2021
• Last Update Posted: January 25, 2023
• Sponsor: ALX Oncology Inc.
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): ALX Oncology Inc.

Tracking Information

• First Submitted Date: July 27, 2021
• First Posted Date: August 12, 2021
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: January 15, 2022
• Estimated Primary Completion Date: July 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2021)

• Phase 2 [ Time Frame: Last randomized patient on study at least 16 weeks ]
  Percentage of patients with objective response per RECIST 1.1
• Phase 3 [ Time Frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose ]
  Overall Survival

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
• Official Title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
• Brief Summary: A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.
• Detailed Description: This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

Phase 2 is Open Label; Phase 3 is blinded

Primary Purpose: Treatment

Condition

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

• Drug: Evorpacept (ALX148)
  IV Q2W
• Drug: Trastuzumab
  IV Q2W
  Other Name: Herceptin
• Drug: Ramucirumab
  IV Q2W
  Other Name: Cyramza
• Drug: Paclitaxel
  IV Days 1, 8, and 15 of a 28-day cycle
  Other Name: Taxol

Study Arms

• 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.
  Interventions:

  • Drug: Evorpacept (ALX148)
  • Drug: Trastuzumab
  • Drug: Ramucirumab
  • Drug: Paclitaxel
• 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.
  Interventions:

  • Drug: Trastuzumab
  • Drug: Ramucirumab
  • Drug: Paclitaxel
• 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.
  Interventions:

  • Drug: Evorpacept (ALX148)
  • Drug: Trastuzumab
  • Drug: Ramucirumab
  • Drug: Paclitaxel
• 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.
  Interventions:

  • Drug: Ramucirumab
  • Drug: Paclitaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 4, 2021): 450
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2028
• Estimated Primary Completion Date: July 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Exclusion Criteria:

• Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
• Prior treatment with any anti-CD47 or anti-SIRPα agent.
• Prior treatment with ramucirumab.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Philip Fanning, PhD; 650-466-7125; info@alxoncology.com

Contact: Sophia Randolph, MD, PhD; 650-466-7125; info@alxoncology.com

• Listed Location Countries: Belgium, Czechia, France, Italy, Japan, Korea, Republic of, Singapore, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05002127
• Other Study ID Numbers: AT148006
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ALX Oncology Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ALX Oncology Inc.
• Original Study Sponsor: Same as current
• Collaborators: Eli Lilly and Company
• Investigators: Not Provided
• PRS Account: ALX Oncology Inc.
• Verification Date: January 2023