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PF-07799933 for Advanced Cancers

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

Diagnosis of advanced/metastatic solid tumor including primary brain tumor

Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective when used alone or in combination with other treatments.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include typical reactions to oral medications like stomach upset, as well as more serious risks such as organ inflammation from immunotherapy drugs. Cetuximab may cause skin reactions and infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My condition worsened after my last treatment and there are no good alternative treatments.

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I have melanoma or colorectal cancer and have received certain approved treatments.

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My cancer has a specific BRAF gene change.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Discontinuations due to AEs (Part 1 and Part 2)

Dose dose modifications due to AEs (Part 1 and Part 2)

Dose interruptions due to AEs (Part 1 and Part 2)

+8 more

Secondary outcome measures

Number of participants with clinically significant physical exam abnormalities (Part 3)

Part 1 and Part 2: Duration of response

Part 1 and Part 2: ORR

+39 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalation (Part 1)Experimental Treatment1 Intervention

Participants will receive PF-07799933

Group II: Dose expansion (Part 3) - Tumor and mutation specific Cohort 2Experimental Treatment2 Interventions

Participants will receive PF-07799933

Group III: Dose expansion (Part 3) - Tumor and mutation specific Cohort 1Experimental Treatment1 Intervention

Participants will receive PF-07799933

Group IV: Combination dose escalation (Part 2)Experimental Treatment3 Interventions

Participants will receive PF-07799933 in combination with binimetinib or cetuximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

binimetinib

2017

Completed Phase 2

~80

cetuximab

2000

Completed Phase 3

~7290

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,910,266 Total Patients Enrolled

51 Trials studying Melanoma

49,280 Patients Enrolled for Melanoma

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,091,380 Total Patients Enrolled

25 Trials studying Melanoma

3,254 Patients Enrolled for Melanoma

Media Library

PF-07799933 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05355701 — Phase 1

Melanoma Research Study Groups: Monotherapy dose escalation (Part 1), Combination dose escalation (Part 2), Dose expansion (Part 3) - Tumor and mutation specific Cohort 1, Dose expansion (Part 3) - Tumor and mutation specific Cohort 2

Melanoma Clinical Trial 2023: PF-07799933 Highlights & Side Effects. Trial Name: NCT05355701 — Phase 1

PF-07799933 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355701 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of individuals taking part in this clinical experiment?

"Indeed, the records on clinicaltrials.gov point to this research being open for enrollment. Initiated on July 5th 2022, and with its most recent update coming November 14th 2022, 174 participants need to join from 15 different medical facilities."

Answered by AI

What are the main aims of this experiment?

"This two-year clinical trial is tracking participants for dose limiting toxicities (DLTs) as its primary outcome. Secondary endpoints include duration of response (DOR), overall response rate evaluated by RECIST version 1.1, and pharmacokinetic parameters in relation to PF-07799933 single doses - namely the area under the plasma concentration time curve from 0 to last quantifiable concentrations (AUClast)."

Answered by AI

Could you enumerate the hospitals in this city that are administering this trial?

"This clinical trial is being run out of the UCHealth Sue Anschutz-Rodgers Eye Center in Aurora, Colorado, University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) in Detroit, Arkansas and University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) in Fayetteville, Tennessee. Moreover, it is also available at 15 other medical centres."

Answered by AI

Has the FDA given its blessing to PF-07799933?

"As this is only a Phase 1 trial, the safety rating for PF-07799933 stands at 1 due to limited clinical data attesting its efficacy and safety."

Answered by AI

Are there any opportunities for participants to join this investigation?

"The details available on clinicaltrials.gov indicate that recruitment for this trial is still in progress, as it was initially posted to the site on July 5th 2022 and updated most recently on November 14th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

2022. "A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05355701.

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