A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

Yajima Yoko0 个研究点目标入组 109 人开始时间: 2021年12月3日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologic solid tumor diagnosis (Part 1).
•Participants enrolled in Part 2 and Part 3(combination dose escalation and expansion) must have non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR)-expressing per central laboratory testing.
•Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•For Part 1 only - history of relapsed/refractory (R/R) disease that has progressed on all standard of care therapy.
•For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
•For Part 3 only - history of RR NSCLC that has progressed on osimertinib
•Meet the laboratory values as described in the protocol.

•History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
•Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
•For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.

发起方

Yajima Yoko