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Protocol NumberAT148006
NCT Number(ClinicalTrials.gov Identfier)NCT05002127
Active

2021-12-27 - 2026-01-17

Phase II/III

Recruiting7

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Kun-Huei Yeh 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang Division of Gastroenterological Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建良 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳新炫 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastric Cancer

Objectives

Phase 2: Primary Objectives • To evaluate the effect of ALX148 plus trastuzumab, ramucirumab, and paclitaxel on objective response rate (ORR) in patients with metastatic HER2-overexpressing gastric/gastroesophageal junction (GEJ) adenocarcinoma who have progressed during or after prior human epidermal growth factor receptor 2 (HER2)-guided therapy and fluoropyrimidine or platinum-based chemotherapy, compared to a historical control group of ramucirumab and paclitaxel alone. • To evaluate the efficacy of ALX148 in response to trastuzumab, ramucirumab, and paclitaxel regimens in patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma who have progressed during or after prior HER2-guided therapy and fluoropyrimidine or platinum-based chemotherapy, by measuring the difference in ORR between two randomized treatment groups. Phase 3 Primary Objective • To evaluate the efficacy of ALX148 plus trastuzumab, ramucirumab, and paclitaxel compared to ramucirumab and paclitaxel in patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma who have progressed during or after prior HER2-guided chemotherapy and fluoropyrimidine or platinum-based chemotherapy.

Test Drug

輸注液

Active Ingredient

ALX148

Dosage Form

27C

Dosage

50 ml/vial

Endpoints

Primary Assessment Indicators

Phase 2:

• Objective response rate (ORR) as assessed by the trial administrator; complete response (CR) or partial response (PR) for solid tumors assessed using the RECIST version 1.1 criteria for response to solid tumors. Discontinued patients will be analyzed as non-responders.

Phase 3:

• Overall survival (OS).

Secondary Assessment Indicators

Phase 2:

• Objective response rate (ORR) as assessed by blinded independent central review (BICR); CR or PR for solid tumors assessed using the RECIST version 1.1 criteria for response to solid tumors.

• Duration of response (DoR), disease control rate (DCR), and time to progression (TTP) as assessed by the trial administrator and BICR.

• Progression-free survival (PFS) and overall survival (OS) as assessed by the trial administrator and BICR.

• Adverse events characterized by type, frequency, severity (according to the National Cancer Institute Common Adverse Event Assessment Criteria [NCI CTCAE] version 5.0), time of occurrence, severity, and relationship to the investigational therapy;

• Laboratory abnormalities characterized by type, frequency, severity (according to NCI CTCAE version 5.0), and time of occurrence;

• Pharmacokinetic exposure of ALX148, such as serum trough concentration (before infusion) and peak concentration (after infusion);

• Immunogenicity characterized by the presence or absence of serum anti-ALX148 antibodies.

Phase 3:

• Objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) as assessed by a blinded independent central review and the trial principal investigator.

• Progression-free survival (PFS) and time to tumor progression (TTP) as assessed by a blinded independent central review and the trial principal investigator. • Adverse events characterized by type, frequency, severity (according to the National Cancer Institute Common Adverse Event Assessment Criteria [NCI CTCAE] version 5.0), time of occurrence, severity, and relationship to the investigational therapy;

• Laboratory abnormalities characterized by type, frequency, severity (according to NCI CTCAE version 5.0), and time of occurrence;

• Pharmacokinetic exposure of ALX148, such as serum ALX148 trough concentration (before infusion) and peak concentration (after infusion);

• Immunogenicity characterized by the presence of serum anti-ALX148 antibodies;

• Quality of life assessed using the EORTC QLQ-C30 and QLQ-STO22 questionnaires.

Inclution 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

Exclusion Criteria:

Patients with known symptomatic central nervous system (CNS) metastases or leptomeningeal disease requiring steroids.
Prior treatment with any anti-CD47 or anti-SIRPα agent.
Prior treatment with ramucirumab.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    450 participants

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