Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.

• Status: Recruiting
• Trial end date: 2024-01-15
• Target enrollment: 0
• Participant gender: All

Summary

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bevacizumab

Criteria

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