Open Actively Recruiting

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

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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)

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

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Study Stats

Protocol No.

20-002161