267 Participants Needed

PF-07799933 for Advanced Cancers

Recruiting at 49 trial locations
PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new medicine, PF-07799933, for individuals with advanced solid tumors, particularly those with a specific gene change called "BRAF." Participants will take this medicine as a pill twice a day. Some with melanoma or other solid tumors might also take another pill called binimetinib, while those with colorectal cancer might receive cetuximab through an IV. The trial targets individuals whose cancer has progressed despite other treatments. Participants should have a solid tumor with a BRAF change and have tried other treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial requires that you stop any ongoing systemic anti-cancer therapy or small molecule therapeutics before starting the study treatment.

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

Research has shown that PF-07799933, whether used alone or with binimetinib, is generally well-tolerated by patients with certain types of cancer. In studies, some patients have demonstrated positive responses to the treatment, both in their bodies and brains. However, PF-07799933 remains in the early stages of testing, so its full safety profile is not yet known.

Combining PF-07799933 with binimetinib or cetuximab may yield better results, depending on the cancer type. As this is an early trial, the primary goal is to assess the safety of these combinations for patients.

While early results appear promising, PF-07799933 and its combinations are still under study and have not yet been approved as safe or effective treatments. Researchers will closely monitor participants in the clinical trial to gather more information on safety and any side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07799933 for advanced cancers because it offers a unique approach compared to current treatments. Unlike standard care options like chemotherapy and targeted therapies, PF-07799933 works by targeting a specific pathway involved in cancer cell growth, potentially offering a more precise attack on cancer cells. This targeted mechanism may lead to fewer side effects and better outcomes for patients. Additionally, PF-07799933 is being tested both as a standalone treatment and in combination with other drugs like binimetinib and cetuximab, which could enhance its effectiveness and broaden its applicability across various cancer types.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Research has shown that PF-07799933 is a new drug targeting specific changes in the BRAF gene, which can cause tumors to grow. In this trial, participants may receive PF-07799933 alone or with other drugs. Specifically, studies have demonstrated that combining PF-07799933 with binimetinib improved outcomes and helped shrink tumors in some patients. Additionally, using PF-07799933 with cetuximab might enhance results for certain cancer types. These findings suggest that PF-07799933 could be an effective treatment option for advanced cancers with BRAF gene changes.12346

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors, including brain tumors, who have a specific abnormal BRAF gene and whose cancer has progressed after treatment. Participants must have tried certain therapies if they have melanoma or colorectal cancer. Those with large brain metastases or certain eye or muscle disorders cannot join.

Inclusion Criteria

I have an advanced cancer that has spread, including to the brain.
My condition worsened after my last treatment and there are no good alternative treatments.
I have melanoma or colorectal cancer and have received certain approved treatments.
See 1 more

Exclusion Criteria

I do not have a history of retinal vein occlusion or muscle disorders with high CK levels.
I am not on any cancer drugs or small molecule treatments as the study starts.
I have a brain tumor larger than 4 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07799933 as a single agent or in combination with binimetinib or cetuximab, depending on the type of solid tumor

2 years
Regular visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Binimetinib
  • Cetuximab
  • PF-07799933

Trial Overview

The study tests PF-07799933 alone and combined with binimetinib for melanoma/other solid tumors, or cetuximab for colorectal cancer. PF-07799933 is an oral tablet; binimetinib is also a tablet; cetuximab is an IV shot given in the clinic.

How Is the Trial Designed?

9

Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalation (Part 1)Experimental Treatment1 Intervention
Group II: Dose expansion (Part 3) - Tumor and mutation specific Cohort 7Experimental Treatment1 Intervention
Group III: Dose expansion (Part 3) - Tumor and mutation specific Cohort 6Experimental Treatment1 Intervention
Group IV: Dose expansion (Part 3) - Tumor and mutation specific Cohort 5Experimental Treatment5 Interventions
Group V: Dose expansion (Part 3) - Tumor and mutation specific Cohort 4Experimental Treatment2 Interventions
Group VI: Dose expansion (Part 3) - Tumor and mutation specific Cohort 3Experimental Treatment2 Interventions
Group VII: Dose expansion (Part 3) - Tumor and mutation specific Cohort 2Experimental Treatment2 Interventions
Group VIII: Dose expansion (Part 3) - Tumor and mutation specific Cohort 1Experimental Treatment1 Intervention
Group IX: Combination dose escalation (Part 2)Experimental Treatment3 Interventions

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

NCT05355701 | A Study to Learn About the ...

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in ...

A Next-Generation BRAF Inhibitor Overcomes Resistance to ...

PF-07799933 (ARRY-440) is a next-generation, selective pan-mutant BRAF inhibitor that is not a pan-RAF inhibitor, does not possess the metabolic liability of ...

Abstract CT178: Phase 1 trial of PF-07799933 (ARRY-440), a ...

As of August 24, 2023 data cutoff, 30 pts with BRAF-mutant cancers started PF-07799933 treatment at 50 mg QD-450 mg BID as monotherapy (60%) or ...

A Study to Learn About the Study Medicine Called PF ...

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in ...

Pfizer's Promising Phase 1 Study on PF-07799933 for ...

The study aims to assess the safety and effects of PF-07799933, both alone and in combination with other treatments, in patients with advanced ...

A Study to Learn About the Study Medicine Called PF ...

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in ...