Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
- Conditions
- Advanced gastrointestinal tumors
- Registration Number
- JPRN-jRCT2080225145
- Lead Sponsor
- Pfizer R&D Japan G.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 130
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method