PF-07062119 for Gastrointestinal Cancer

No longer recruiting at 19 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Immunosuppressants

Disqualifiers: CNS metastases, Other malignancy, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PF-07062119 for advanced gastrointestinal cancers, such as colorectal, gastric, or esophageal cancer. Researchers aim to evaluate the effectiveness of this treatment both alone and in combination with other drugs that enhance the immune system's ability to fight cancer. The trial seeks participants whose cancer is resistant to standard treatments. Those who have not had success with other treatments may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had any anti-cancer treatment within 4 weeks before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07062119, whether used alone or with other drugs, is under careful study for safety in treating stomach and intestinal cancers. Earlier studies tested different doses of PF-07062119 on individuals with advanced stomach and gut cancers. The results suggested that the treatment is generally safe, as it usually did not cause serious side effects for most participants.

When combined with anti-VEGF, a drug that stops tumors from receiving blood supply, PF-07062119 was well-tolerated in animal studies. This suggests potential safety for humans, though further research is necessary. Similarly, combining it with anti-PD-1, another cancer drug, remains under investigation.

Overall, as this is a phase 1 trial, it represents an early step in assessing the safety of PF-07062119 in humans. This phase focuses on determining the right dose and identifying any side effects. So far, the treatment appears promising, but more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for gastrointestinal cancer, like chemotherapy and targeted therapies, work by attacking rapidly dividing cells or specific proteins in cancer cells. But PF-07062119 works differently. It targets pathways involving VEGF and PD-1, which are crucial for tumor blood supply and immune evasion. Researchers are excited because this dual-action approach could potentially cut off the tumor's blood supply while boosting the immune system's ability to fight cancer cells. This innovative mechanism might offer new hope for patients who haven't responded well to standard treatments.

What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?

Research has shown that PF-07062119 could aid in treating advanced gastrointestinal cancers. In earlier studies, this treatment, which enhances the immune system's T-cells to target cancer, proved effective against tumors with a specific marker called Guanylyl Cyclase C (GUCY2C). This enables the immune system to locate and attack cancer cells more effectively. In this trial, participants may receive PF-07062119 alone or with other treatments that block cancer growth, such as anti-VEGF or anti-PD-1. These combinations have shown promise in improving outcomes for patients with colorectal and other gastrointestinal cancers by preventing cancer cells from growing and evading the immune system. Overall, early results suggest that PF-07062119 might offer a new approach to managing these challenging cancers. ^{1 2 3 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Measurable disease as defined by RECIST 1.1 is required (Part 2)

My cancer can be measured or is not responding to current treatments.

My colorectal cancer does not respond to standard treatments.

Exclusion Criteria

Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry

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

I haven't had cancer treatment in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Successive cohorts of patients receive escalating doses of PF-07062119 as a single agent

28 days

Multiple visits for dose escalation

Dose Finding

PF-07062119 is administered in combination with anti-PD-1 and anti-VEGF to determine optimal dosing

28 days

Multiple visits for combination therapy

Dose Expansion

PF-07062119 is administered in expansion arms as a single agent and in combination with anti-PD-1 and anti-VEGF

4 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anti-PD1
• Anti-VEGF
• PF-07062119

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Finding anti-VEGF Combination Experimental Treatment 2 Interventions

Part 1B PF-07062119 plus anti-VEGF

Group II: Dose Finding Anti-PD-1 Combination Experimental Treatment 2 Interventions

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

Group III: Dose Expansion Arm D Experimental Treatment 3 Interventions

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

Group IV: Dose Expansion Arm C Experimental Treatment 3 Interventions

PF-07062119 in Combination with anti-VEGF in CRC

Group V: Dose Expansion Arm B Experimental Treatment 1 Intervention

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

Group VI: Dose Expansion Arm A Experimental Treatment 1 Intervention

PF-07062119 as a Single Agent in CRC

Group VII: Dose Escalation Experimental Treatment 1 Intervention

Single Agent Dose Escalation

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31996389/

A Novel GUCY2C-CD3 T-Cell Engaging Bispecific ... We demonstrate potent, tumor-selective efficacy with PF-07062119, a T-cell engaging CD3 bispecific targeting tumors expressing Guanylyl Cyclase C (GUCY2C).

2. aacrjournals.org aacrjournals.org/clincancerres/article/26/9/2188/83190/A-Novel-GUCY2C-CD3-T-Cell-Engaging-Bispecific

A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct ... These data highlight the potential for PF-07062119 to demonstrate efficacy and improve patient outcomes in colorectal cancer and other gastrointestinal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04171141

Study to Test the Safety and Tolerability of PF-07062119 in ... This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 ...

4. cdn.pfizer.com cdn.pfizer.com/pfizercom/clinical%20trials/csr%20synopsis/C3861001%20Public%20Disclosure%20Synopsis%20.pdf?VersionId=RpPJrU8zA4XIHRvYpaXtPV8O231eKCEy

clinical study report synopsis In conclusion, PF-07062119 exhibited a relatively favorable benefit-risk profile and modest clinical activity in advanced/metastatic gastrointestinal tumors.

5. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-19-3275/75923/am/A-Novel-GUCY2C-CD3-T-cell-Engaging-Bispecific

A Novel GUCY2C-CD3 T cell Engaging Bispecific construct ... Conclusion: These data highlight the potential for PF-07062119 to demonstrate efficacy and improve patient outcomes in CRC and other gastrointestinal ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04171141/

Clinical Trial: NCT04171141 Brief Title: Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8578158/

Preclinical Evaluation of 89Zr-Df-IAB22M2C PET as an ... Specifically, PF-07062119 showed potent T cell–mediated in vitro activity and in vivo efficacy in multiple human colorectal cancer xenograft tumor models, ...