2025-522012-16-00尚未招募2 期
Master Protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09) Substudy Protocol: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 21
- 主要终点
- 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.
研究概览
简要总结
To evaluate the overall response rate of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) who have HER2 copy number amplification in ctDNA at baseline (ctDNA+).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Substudy Protocol
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Master Protocol • Participants must have at least one measurable lesion as defined by RECIST v1.
- •Substudy Protocol: • Progressed on or following the most recent line of therapy
- •Substudy Protocol: • LVEF ≥50%
- •Substudy Protocol: • Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)
- •Substudy Protocol: • Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
- •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).
- •Master Protocol • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to
- •Master Protocol • Life expectancy of at least 3 months
- •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
- •Substudy Protocol: • Histologically confirmed invasive HER2 positive breast cancer
- •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.
排除标准
- •Master Protocol: • Participants with known CNS metastases unless treated and stable prior to enrollment
- •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).
- •Master Protocol: • Has an active autoimmune disease that has required systemic treatment in past 2 years
- •Substudy Protocol: • Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
- •Substudy Protocol: • Other primary malignancy within 2 years
- •Substudy Protocol: • Any condition that would be contraindicated to receiving trastuzumab
- •Master Protocol: • Following anti-cancer therapy with insufficient washout :
- •chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days
- •Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days
- •Master Protocol: • Prior exposure to any anti-CD47 or anti-SIRPα agent.
- •Master Protocol: • History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
- •Master Protocol: • Had an allogeneic tissue/solid organ transplant.
- •Master Protocol: • Any active, unstable cardiovascular disease
研究组 & 干预措施
evorpacept
Experimental
Participants receiving evorpacept
干预措施: evorpacept (Drug)
结局指标
主要结局
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.
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.
次要结局
- • ORR based on Investigator assessment.
- • 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).
- • 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.
- • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0) and timing.
- • 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.
- • Presence of human serum anti-drug antibodies (ADAs) (anti-evorpacept antibodies).
研究者
ALX Oncology Inc.
Scientific
Alx Oncology Holdings Inc.
研究点 (21)
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