What side effects are associated with this type of intervention?

Common treatments for advanced or metastatic gastrointestinal tumors, such as tyrosine kinase inhibitors (TKIs) targeting vascular endothelial growth factor receptors (VEGFR), often have side effects including hypertension, diarrhea, hypothyroidism, and hand-foot syndrome. Other potential adverse effects include nausea, fatigue, and mucosal inflammation. These side effects are generally related to the antiangiogenic properties of the drugs, which can impact various physiological processes.

What prior FDA approvals exist?

The FDA has approved several molecularly targeted agents and immunotherapies for the treatment of advanced or metastatic gastrointestinal tumors. Notable approvals include pembrolizumab, an anti-PD-1 monoclonal antibody, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including gastrointestinal cancers. Additionally, trastuzumab, a HER2 inhibitor, is approved for HER2-overexpressing gastric and gastroesophageal junction adenocarcinomas. Ramucirumab, a VEGF receptor 2 antagonist, is approved for advanced gastric or gastroesophageal junction adenocarcinoma. These therapies represent significant advancements in the treatment of gastrointestinal tumors, offering targeted approaches that improve patient outcomes.

What other types of research exist?

Promising novel alternatives for gastrointestinal tumor patients include: 1) Aflibercept plus FOLFIRI, which has shown significant improvements in overall survival, progression-free survival, and response rate in metastatic colorectal cancer. 2) TAS-102 in combination with bevacizumab, cetuximab, or panitumumab, which has shown promise in preclinical studies for colorectal cancer. 3) Immune checkpoint inhibitors, which hold great promise for metastatic small bowel adenocarcinoma based on emerging evidence.

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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

Must not have

Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases

Major surgery or radiation within 3 weeks prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, PF-07062119, alone and with other treatments in patients with advanced gastrointestinal cancers. The goal is to see if these treatments can help the immune system fight cancer and stop tumors from growing by cutting off their blood supply.

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.

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.

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.

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My colorectal cancer does not respond to standard treatments.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active and uncontrolled brain metastases.

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I have not had major surgery or radiation in the last 3 weeks.

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I have or had an autoimmune disease that needed strong medication.

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I have or had a serious stomach or intestine disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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-PD1

2023

N/A

~10

Anti-VEGF

2013

Completed Phase 2

~430

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastrointestinal tumors include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as tyrosine kinase inhibitors, work by blocking specific molecules involved in tumor growth and progression, thereby inhibiting cancer cell proliferation. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against cancer cells by blocking proteins that prevent immune cells from attacking tumors. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are crucial for gastrointestinal tumor patients as they offer multiple mechanisms to control tumor growth, improve survival rates, and potentially reduce tumor burden, especially in advanced or metastatic stages.

Pharmacotherapy for oesophagogastric cancer.Exploiting molecular targets in pancreatic cancer.