PF-07799544 for Cancer

Recruiting at 70 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Brain metastasis, Retinal vein occlusion, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new medicine, PF-07799544, for individuals with advanced solid tumors unresponsive to other treatments. Participants will take PF-07799544 alone or with other medicines, particularly if they have melanoma or specific genetic traits linked to their cancer. This trial suits those whose cancer has spread and isn't responding to current treatments. Participants will take the medicine as a tablet and may continue treatment for about two years, with regular clinic check-ups. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

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

Research shows that PF-07799544 remains under investigation, and its safety and effectiveness are not yet fully understood. This drug is being tested alone and with another drug, PF-07799933, in individuals with advanced cancer. As this study is in its early stages, the primary goal is to determine the drug's safety for humans.

Currently, specific information about side effects or patient tolerance of PF-07799544, alone or in combination with PF-07799933, is unavailable. As a Phase 1 study, it primarily aims to test safety and establish the correct dosage. This phase involves testing the drugs in humans for the first time, with close monitoring of any potential side effects. Participants undergo regular evaluations to assess their response to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07799544 because it represents a new approach in cancer treatment by potentially targeting specific cancer cell pathways that current therapies might not address. Unlike standard treatments like chemotherapy and radiation, which can impact both cancerous and healthy cells, PF-07799544 is designed to selectively disrupt cancer cell growth, aiming to minimize side effects. Additionally, the combination of PF-07799544 with PF-07799933 could enhance its effectiveness, offering hope for improved outcomes in patients with challenging or resistant forms of cancer.

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

Research shows that PF-07799544 is a MEK inhibitor, targeting a protein that aids cancer cell growth. Although the safety and effectiveness are still under study, early results suggest potential benefits for patients with solid tumors. In this trial, some participants will receive PF-07799544 alone, while others will receive it with another study drug, PF-07799933. Researchers are particularly interested in its effects on advanced melanoma when combined with PF-07799933. While conclusive evidence about its effectiveness is not yet available, the mechanism of PF-07799544 offers hope for slowing cancer growth. ^{1 2 6 7 8}

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 people with advanced solid tumors, including brain and metastatic melanoma, where standard treatments no longer work. Participants need measurable disease by RECIST v1.1 criteria and must have progressed after the last treatment without other options. For certain substudies, a BRAF V600 mutation is required.

Inclusion Criteria

My cancer has a specific BRAF gene change.

My advanced cancer, except melanoma, didn't respond to standard treatments.

I have an advanced cancer that has spread, including brain cancer.

Exclusion Criteria

I have a brain tumor larger than 4 cm.

I have or had a blocked vein in my eye or a muscle disorder with high CK levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07799544 as a single agent or in combination with other study medicines for advanced solid tumors

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

• encorafenib
• PF-07284890
• PF-07799544
• PF-07799933

Trial Overview The study tests PF-07799544 as a single agent or combined with other drugs in tablet form for advanced tumor patients. Some may also take encorafenib or additional study medicines like PF-07284890 or PF-07799933 depending on their gene type and study part.

How Is the Trial Designed?

Group I: Phase 1b Substudy C Combination Dose Expansion Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group II: Phase 1b Substudy B Combination Dose Expansion Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group III: Phase 1b Substudy B Combination Dose Escalation Experimental Treatment 2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group IV: Monotherapy Dose Escalation (Phase 1a) Experimental Treatment 2 Interventions

Participants will receive PF-07799544

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

Published Research Related to This Trial

In a real-world study involving 196 patients with metastatic colorectal cancer, the combination of bevacizumab and chemotherapy resulted in a median progression-free survival of 8.22 months, demonstrating its efficacy as a first-line treatment.

The treatment was generally safe, with the most common adverse event being hypertension (28%), and only 15.2% of patients experiencing severe (Grade 3/4) adverse events, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Non-Interventional Multicenter Study of First-Line Bevacizumab in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer in Lebanon. Temraz, S., Nasr, F., Kattan, J., et al.[2022]

The study found that the likelihood of translating a progression-free survival (PFS) benefit into an overall survival (OS) benefit is significantly influenced by the crossover rate and the length of survival post-progression (SPP).

Specifically, a crossover rate greater than 50% can greatly reduce the chances of observing an OS benefit, especially when combined with longer SPP times, indicating that these factors must be carefully considered in clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study. Zhang, L., Ko, CW., Tang, S., et al.[2020]

In a review of 20 clinical trials involving 7,571 patients with metastatic colorectal cancer, targeted agents showed only minimal improvements in progression-free survival (PFS) and modest gains in overall survival (OS), suggesting limited efficacy in the second-line treatment.

The study found a moderate correlation between PFS and OS (R=0.734), but a poor correlation between objective response rate (ORR) and OS (R=0.169), indicating that OS should remain the primary endpoint in future trials for more reliable efficacy assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surrogate Endpoints in Second-Line Trials of Targeted Agents in Metastatic Colorectal Cancer: A Literature-Based Systematic Review and Meta-Analysis. Cremolini, C., Antoniotti, C., Pietrantonio, F., et al.[2022]

Overall survival (OS) is the traditional measure of clinical benefit for cancer drugs, but it requires large studies and long follow-up times, making it less practical for assessing new treatments quickly.

Progression-free survival (PFS) and time to progression (TTP) are valuable alternative endpoints that directly measure the effects of treatments on cancer growth, and their improvement can indicate clinical benefit, potentially speeding up the development and availability of effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Zhuang, SH., Xiu, L., Elsayed, YA.[2022]

In a phase 3 trial involving 1717 men with metastatic castration-resistant prostate cancer, enzalutamide significantly reduced the risk of radiographic progression or death, demonstrating its efficacy as a treatment option.

The study confirmed a strong correlation between radiographic progression-free survival (rPFS) and overall survival (OS), supporting the use of rPFS as a meaningful endpoint in clinical trials for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. Rathkopf, DE., Beer, TM., Loriot, Y., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05538130

NCT05538130 | A Study to Learn About the ... This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer.

2. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT05538130

Clinical Trial Details | Pfizer Oncology Development Website MEK Brain Penetrant Inhibitor. PF-07799544 is an investigational compound. Its safety and efficacy have not been established.

3. withpower.com withpower.com/trial/phase-1-non-small-cell-lung-carcinoma-nsclc-10-2022-d4699

PF-07799544 for Cancer What data supports the effectiveness of the drug PF-07799544 for cancer? The ... survival of 8.22 months, demonstrating its efficacy as a first-line treatment.

4. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/molecule/mek-brain-penetrant-inhibitor

MEK Brain Penetrant Inhibitor MEK Brain Penetrant Inhibitor. PF-07799544 is an investigational compound. Its safety and efficacy have not been established. Go to section ...

5. mskcc.org mskcc.org/cancer-care/clinical-trials/24-291

A Phase 1 Study of PF-07799544 Plus PF-07799933 in ... Researchers want to find the best doses of PF-07799544 and PF-07799933 to use in people with advanced melanoma.

6. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct05538130-melanoma-trial

A Study to Learn About the Study Medicine Called PF ... The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination ...

7. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/C4901001

PF-07799544 as a Single Agent and in Combination With ... This study focuses on people who have melanoma (skin cancer) or other cancer with a specific change in the BRAF gene (BRAF alteration) and whose.

8. my.clevelandclinic.org my.clevelandclinic.org/clinical-trials/1750-a-phase-1ab-open-label-master-study-of-pf-07799544-as-a-single-agent-and-in-combination-with-other-targeted-agents-in-participants-with-advanced-solid-tumors

A Phase 1a/b Open-Label Master Study of PF-07799544 ... To assess the safety and tolerability of PF-07799544 at increasing dose levels and to estimate the MTD and select the MTDM/RDEM as a single agent in ...