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

NCT04171141

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas

Interventions: PF-07062119, Anti-PD1, Anti-VEGF

Countries: United States, Australia, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (19)

Duarte, California, United States
Duarte, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Grand Rapids, Michigan, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Kashiwa, Chiba, Japan
Chuo-ku, Tokyo, Japan