A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

Pfizer R&D Japan G.K.0 个研究点目标入组 130 人开始时间: 2020年3月30日最近更新: 2023年10月17日

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label)

•Inclusion Criteria:
•* For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
•* For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
•* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
•* Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
•* Measurable disease as defined by RECIST 1.1 is required (Part 2)

•Exclusion Criteria:
•* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
•* Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
•* Major surgery or radiation within 3 weeks prior to study entry
•* Last anti-cancer treatment within 4 weeks prior to study entry
•* Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication
•* Active or history of clinically significant gastrointestinal disease
•* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry
•* Pregnant or breastfeeding female patients

发起方

Pfizer R&D Japan G.K.