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Monoclonal Antibodies

PF-07062119 for Gastrointestinal Cancer

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (1st dosing) up to approximately 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to treat gastrointestinal tumors. It is open to patients with advanced or metastatic gastrointestinal tumors.

Who is the study for?

This trial is for adults with advanced or metastatic gastrointestinal cancers, like colorectal, stomach, or esophageal cancer that don't respond to standard treatments. Participants must be in good physical condition (ECOG PS 0 or 1) and not have had major surgery or other cancer drugs within the last few weeks. Pregnant women and those with autoimmune diseases, active CNS metastases, or another recent cancer are excluded.Check my eligibility

What is being tested?

The study is testing PF-07062119's safety at different doses in patients with specific gastrointestinal tumors. It's an early-phase trial (phase 1), meaning it's primarily looking at how well patients can tolerate this new drug and what effects it has on their bodies.See study design

What are the potential side effects?

Possible side effects of PF-07062119 may include typical reactions to anti-cancer drugs such as fatigue, nausea, increased risk of infection due to a weakened immune system, skin reactions from anti-VEGF therapy like rash or dry skin, and potential complications related to immune response from Anti-PD1 treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer of the colon, stomach, or esophagus does not respond to standard treatments.

Select...

My colorectal cancer does not respond to standard treatments.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (1st dosing) up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (1st dosing) up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (1st dosing) up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of Adverse Events (AEs)

Number of Participants With Adverse Events (AEs) According to Seriousness

Number of Participants With Adverse Events (AEs) According to Severity

+4 more

Secondary outcome measures

Apparent Clearance (CL/F)

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

+12 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Finding anti-VEGF CombinationExperimental Treatment2 Interventions

Part 1B PF-07062119 plus anti-VEGF

Group II: Dose Finding Anti-PD-1 CombinationExperimental Treatment2 Interventions

Part 1B PF-07062119 plus anti-PD-1

Group III: Dose Expansion Arm DExperimental Treatment3 Interventions

PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types

Group IV: Dose Expansion Arm CExperimental Treatment3 Interventions

PF-07062119 in Combination with anti-VEGF in CRC

Group V: Dose Expansion Arm BExperimental Treatment1 Intervention

PF-07062119 in Combination with anti-PD-1 in CRC

Group VI: Dose Expansion Arm AExperimental Treatment1 Intervention

PF-07062119 as a Single Agent in CRC

Group VII: Dose EscalationExperimental Treatment1 Intervention

Single Agent Dose Escalation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-VEGF

2013

Completed Phase 2

~400

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,575 Previous Clinical Trials

10,923,022 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,482 Previous Clinical Trials

8,099,284 Total Patients Enrolled

Media Library

PF-07062119 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04171141 — Phase 1

PF-07062119 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04171141 — Phase 1

Gastrointestinal Tumors Research Study Groups: Dose Finding anti-VEGF Combination, Dose Expansion Arm C, Dose Expansion Arm B, Dose Expansion Arm A, Dose Escalation, Dose Finding Anti-PD-1 Combination, Dose Expansion Arm D

Gastrointestinal Tumors Clinical Trial 2023: PF-07062119 Highlights & Side Effects. Trial Name: NCT04171141 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are actively participating in this clinical trial?

"Currently, 14 medical centres are recruiting potential participants. These sites can be found in New york, Houston and Cleveland as well as 11 other locations across the country. To reduce travel needs, it is recommended to select an enrolment site close to your residence."

Answered by AI

To what upper limit are participants enrolled in this clinical trial?

"Yes, according to the clinicaltrials.gov records, this study is still actively recruiting participants. The research began on November 19th 2019 and was revised as of November 17th 2022; with expectations that 130 individuals will be accepted across 14 different medical centres."

Answered by AI

Is participation in this experiment currently open to the public?

"The information hosted on clinicaltrials.gov confirms that this trial is actively in search of participants. The original publication date was November 19th 2019, and the most recent edits were made on November 17th 2022."

Answered by AI

Has the FDA sanctioned PF-07062119 for use?

"Our team has determined PF-07062119 to be of low safety risk, as evidenced by its Phase 1 classification. This indicates that there is limited data demonstrating both efficacy and safety at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171141.