What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as chemotherapy (e.g., temozolomide), targeted therapies (e.g., bevacizumab), and radiation therapy, often have several side effects. Chemotherapy can cause hematologic toxicity, nausea, fatigue, and increased risk of infections. Targeted therapies may lead to hypertension, proteinuria, and increased risk of bleeding or thromboembolic events. Radiation therapy is associated with neurocognitive decline, fatigue, and potential long-term effects like secondary cancers. These side effects reflect the impact of treatments that target pathways involved in tumor growth and survival.

What prior FDA approvals exist?

Several FDA-approved drugs target pathways involved in tumor growth and survival for the treatment of brain tumors. Enzalutamide, approved for metastatic castration-resistant prostate cancer, targets the androgen receptor pathway and has shown limited activity in brain tumors. Bevacizumab, an anti-angiogenic agent, is approved for recurrent glioblastoma and works by inhibiting vascular endothelial growth factor (VEGF). Temozolomide, an oral alkylating agent, is widely used for glioblastoma and works by damaging DNA in cancer cells. Additionally, B-raf inhibitors like vemurafenib and dabrafenib have shown activity in brain metastases from melanoma by targeting the BRAF V600E mutation. These treatments highlight the focus on targeting specific molecular pathways to inhibit tumor growth and survival.

What other types of research exist?

<ol> <li>MS-444: A small molecule inhibitor of HuR, shown to induce apoptosis and reduce invasion in glioblastoma cells. 2.</li> </ol> GDC-0084: An oral, brain-penetrant PI3K/mTOR inhibitor with demonstrated safety and activity in a phase I study for high-grade glioma. 3. AZD9291: A third-generation EGFR inhibitor that efficiently inhibits EGFR/ERK signaling in glioblastoma cells, with preclinical evidence of efficacy. 4. T11TS: A novel antineoplastic agent that reverses immunosuppression, arrests the cell cycle, and induces apoptosis in glioma cells, with promising preclinical results.

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PF-07799544 for Cancer

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer medicine, PF-07799544, taken regularly as a tablet. It is for people with advanced solid tumors who haven't responded to other treatments. The medicine may be used alone or with other drugs to improve its effectiveness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones from cancer medications include nausea, fatigue, skin reactions, increased risk of infection, liver function changes, and potential drug-specific effects which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase)

Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase)

Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase)

+3 more

Secondary study objectives

Intracranial response (phase 1b Part 2)

Number of participants with clinically significant change from baseline in laboratory abnormalities

Number of participants with clinically significant change from baseline in vital sign abnormalities

+28 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 1b Substudy C Combination Dose ExpansionExperimental Treatment2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group II: Phase 1b Substudy B Combination Dose ExpansionExperimental Treatment2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group III: Phase 1b Substudy B Combination Dose EscalationExperimental Treatment2 Interventions

Participants will receive PF-07799544 and PF-07799933

Group IV: Monotherapy Dose Escalation (Phase 1a)Experimental Treatment2 Interventions

Participants will receive PF-07799544

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

encorafenib

2019

Completed Phase 2

~160

Do I qualify?Apply below to find out

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 brain tumors often target specific pathways involved in tumor growth and survival. Molecularly targeted therapies, such as those being studied with PF-07799544, aim to inhibit key proteins and signaling pathways that cancer cells rely on for proliferation and survival. For example, drugs targeting the BRAF gene mutations in melanoma can disrupt tumor growth. Immunotherapies, like CAR T-cell therapy, enhance the immune system's ability to recognize and destroy cancer cells. Traditional treatments like chemotherapy and radiation work by damaging the DNA of rapidly dividing cells, leading to cell death. Understanding these mechanisms is crucial for brain tumor patients as it helps in selecting the most effective treatment strategy based on the tumor's specific molecular characteristics.

Bioinformatics analysis reveals potential candidate drugs for different subtypes of glioma.Current and emerging molecular targets in glioma.