EVORPACEPT for Breast cancer | Metastatic breast cancer | HER2-positive breast cancer

Inclusion criteria

• {"criterion_text":"- Master Protocol • Participants must have at least one measurable lesion as defined by RECIST v1.1.\n- Substudy Protocol: • Progressed on or following the most recent line of therapy\n- Substudy Protocol: •\tLVEF ≥50%\n- Substudy Protocol: • Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)\n- Substudy Protocol: • Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation\n- Substudy Protocol: • Adequate liver function: • Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome); • Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).\n- Master Protocol • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.\n- Master Protocol • Life expectancy of at least 3 months\n- Master Protocol • Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment\n- Substudy Protocol: • Histologically confirmed invasive HER2 positive breast cancer\n- Substudy Protocol: • Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease."}

Exclusion criteria

• {"criterion_text":"- Master Protocol: • Participants with known CNS metastases unless treated and stable prior to enrollment\n- Master Protocol: • Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).\n- Master Protocol: • Has an active autoimmune disease that has required systemic treatment in past 2 years\n- Substudy Protocol: • Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen\n- Substudy Protocol: • Other primary malignancy within 2 years\n- Substudy Protocol: • Any condition that would be contraindicated to receiving trastuzumab\n- Master Protocol: • Following anti-cancer therapy with insufficient washout : 1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days 2.\tImmune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days\n- Master Protocol: • Prior exposure to any anti-CD47 or anti-SIRPα agent.\n- Master Protocol: • History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.\n- Master Protocol: • Had an allogeneic tissue/solid organ transplant.\n- Master Protocol: • Any active, unstable cardiovascular disease"}

Primary endpoints

• {"endpoint_text":"- Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on Blinded Independent Central Review (BICR) assessment.","definition_or_measurement_approach":"ORR assessed using RECIST v1.1 based on Blinded Independent Central Review (BICR) assessment."}

Secondary endpoints

• {"endpoint_text":"- • ORR based on Investigator assessment.","definition_or_measurement_approach":"Investigator-assessed ORR per RECIST v1.1."}
• {"endpoint_text":"- • Clinical Benefit Rate (CBR), Duration of Response (DoR), and Progression Free Survival (PFS), using RECIST v1.1 based on BICR and Investigator assessment, and Overall Survival (OS).","definition_or_measurement_approach":"CBR, DoR, PFS per RECIST v1.1 assessed by BICR and Investigator; OS measured as time to death from any cause."}
• {"endpoint_text":"- • Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]), timing, seriousness, and relationship to study drug.","definition_or_measurement_approach":"AEs graded per NCI CTCAE v5.0; collected and summarized by type, frequency, severity, timing, seriousness, and relationship to study drug."}
• {"endpoint_text":"- • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0) and timing.","definition_or_measurement_approach":"Laboratory abnormalities graded per NCI CTCAE v5.0 and summarized by type, frequency, severity, and timing."}
• {"endpoint_text":"- • PK parameters of evorpacept such as maximum concentration (Cmax), time at maximum concentration (Tmax), area under the concentration-time curve (AUC), clearance (CL), and terminal elimination half-life (t1/2) as data permit.","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, Tmax, AUC, CL, t1/2) measured from blood samples per protocol PK sampling schedule."}
• {"endpoint_text":"- • Presence of human serum anti-drug antibodies (ADAs) (anti-evorpacept antibodies).","definition_or_measurement_approach":"Immunogenicity assessed by detecting anti-evorpacept antibodies in human serum samples."}

Methods

• K1/K2 Recruitment documents provided per country (document titles indicate use of a 'Recruitment Procedure' and 'Recruitment Material_Referral Letter') — country-specific recruitment materials available for France, Italy and Spain (document titles present in record).

France

Earliest CTIS Part Ii Submission Date

04-11-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

80

Number Of Sites

6

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

10-10-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

105

Number Of Sites

8

Number Of Participants

11

Spain

Earliest CTIS Part Ii Submission Date

22-12-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

32

Number Of Sites

7

Number Of Participants

13

Primary sponsor

Full Name

Alx Oncology Holdings Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

CRO

Third parties

• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Safety Database","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Sitero LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Medical image analysis, primary endpoint test","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"receptor occupancy/immunophenotyping","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"","organisation_type":"Pharmaceutical company"}