PF-07062119 for Gastrointestinal Cancer

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

79 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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