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PF-07284892 Combination Therapy for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor. Participants with ROS-positive NSCLC are also eligible for Part 1 and 2 (Other ROS1-positive solid tumors may be considered after discussion with the sponsor).
Part 3: ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort 1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no prior lorlatinib (Cohort 3).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 2 years
Awards & highlights
Study Summary
This trial is to test the safety and effectiveness of a new drug, PF-07284892, either alone or in combination with other drugs, in treating cancer.
Who is the study for?
Adults with certain advanced solid tumors, including lung cancer (ALK-positive NSCLC), colorectal cancer with BRAF V600E mutation, or other specific mutations. Participants must have tried standard treatments and be free from large brain metastases and recent anti-cancer therapies.Check my eligibility
What is being tested?
PF-07284892 is being tested alone and in combination with lorlatinib, encorafenib plus cetuximab, or binimetinib to find the safest dose for future studies. The trial will also assess how the body processes these drugs and their preliminary effects on tumors.See study design
What are the potential side effects?
Potential side effects may include risks associated with each drug: lung issues from lorlatinib or encorafenib; vision problems like retinal vein occlusion from binimetinib; general risks of fatigue, digestive discomfort, skin reactions, and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is ALK-positive NSCLC, CRC with BRAF V600E, or has specific mutations.
Select...
My NSCLC is ALK-positive. I may or may not have had lorlatinib or platinum-based chemotherapy.
Select...
I am 18 years old or older.
Select...
My tumor has specific genetic mutations and I've had standard treatment.
Select...
I have paperwork showing the genetic changes in my cancer.
Select...
My colorectal cancer is BRAF V600E mutant and has not responded to or has not been treated with BRAFi and EGFRi.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and Part 2 - Number of dose interruptions, dose modifications, and discontinuations due to AEs
Part 1 and Part 2 - Number of participants with clinically significant change from baseline in laboratory abnormalities
Part 1 and Part 2- Number of participants with dose limiting toxicities (DLTs)
+2 moreSecondary outcome measures
Part 1 and Part 2- Area under the plasma concentration-time curve from 0 to 24 (AUC24) or 48 hours (AUC48) of PF-07284892 and metabolite
Part 1 and Part 2- Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUCinf) of PF-07284892 and metabolite
Part 1 and Part 2- Area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) of PF-07284892 and metabolite
+5 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: PF-07284892 monotherapyExperimental Treatment1 Intervention
Monotherapy dose escalation of PF-07284892 in participants with ALK- or ROS1-positive non-small cell lung cancer (NSCLC), B-type Raf proto-oncogene V600E mutation colorectal cancer (CRC), or RAS- mutant, NF1-mutant or BRAF class 3-mutant solid tumors
Group II: PF-07284892 in combination with lorlatinib (Part 2)Experimental Treatment2 Interventions
Combination dose escalation of PF-07284892 in combination with lorlatinib in participants with ALK- or ROS1-positive NSCLC
Group III: PF-07284892 in combination with encorafenib and cetuximab (Part 2)Experimental Treatment3 Interventions
Combination dose escalation of PF-07284892 in combination with encorafenib and cetuximab in participants with BRAF V600E mutant CRC
Group IV: PF-07284892 in combination with binimetinib (Part 2)Experimental Treatment2 Interventions
Combination dose escalation of PF-07284892 in combination with binimetinib in participants with Ras-mutant, NF-1 mutant or BRAF class 3 -mutant solid tumors
Group V: Expansion Phase (Cohort 5)Experimental Treatment4 Interventions
PF-07284892 + binimetinib in participants with RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior standard of care (SOC)
Group VI: Expansion Phase (Cohort 4)Experimental Treatment3 Interventions
PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC with no prior BRAFi plus EGFRi
Group VII: Expansion Phase (Cohort 3)Experimental Treatment4 Interventions
PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC with prior BRAF inhibitor (BRAFi) plus epidermal growth factor receptor inhibitor (EGFRi)
Group VIII: Expansion Phase (Cohort 2)Experimental Treatment2 Interventions
PF-07284892 + lorlatinib in participants with ALK+ NSCLC with no prior lorlatinib
Group IX: Expansion Phase (Cohort 1)Experimental Treatment2 Interventions
PF-07284892 + lorlatinib in participants with ALK+ NSCLC with prior lorlatinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
binimetinib
2017
Completed Phase 2
~80
encorafenib
2019
Completed Phase 2
~100
lorlatinib
2020
N/A
~550
cetuximab
2000
Completed Phase 3
~7290
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,820 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,988 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is ALK-positive NSCLC, CRC with BRAF V600E, or has specific mutations.My NSCLC is ALK-positive. I may or may not have had lorlatinib or platinum-based chemotherapy.I do not have a history of retinal vein occlusion or muscle disorders with high CK levels.I haven't taken any cancer drugs or had antibody treatments in the weeks before starting this study.I am 18 years old or older.My tumor has specific genetic mutations and I've had standard treatment.I have paperwork showing the genetic changes in my cancer.I have a brain tumor larger than 4 cm.My colorectal cancer is BRAF V600E mutant and has not responded to or has not been treated with BRAFi and EGFRi.I have never had interstitial lung disease.I have had cancer within the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Phase (Cohort 5)
- Group 2: PF-07284892 in combination with lorlatinib (Part 2)
- Group 3: Expansion Phase (Cohort 1)
- Group 4: Expansion Phase (Cohort 2)
- Group 5: Expansion Phase (Cohort 4)
- Group 6: PF-07284892 in combination with encorafenib and cetuximab (Part 2)
- Group 7: PF-07284892 in combination with binimetinib (Part 2)
- Group 8: Expansion Phase (Cohort 3)
- Group 9: PF-07284892 monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any more slots available for this clinical trial?
"Affirmative. Clinicaltrials.gov suggests that this investigation is actively searching for participants, with 211 patients needed to be recruited from 8 sites since its posting on March 17th 2021 and most recent update on February 15th 2022."
Answered by AI
Is PF-07284892 authorized by the FDA?
"Our team at Power has assigned PF-07284892 a score of 1, as this clinical trial is only in its first phase and there is limited evidence regarding safety or efficacy."
Answered by AI
How many participants have been included in the trial thus far?
"This trial requires a total of 211 patients who qualify according to the criteria listed. Participants can join at either Tennessee Oncology PLLC in Franklin and Houston, Texas or any California site."
Answered by AI
Are there any additional investigations regarding PF-07284892?
"PF-07284892 was first tested in 2007 at Royal Bournemouth Hospital and has since undergone 410 trials. Currently, 191 studies are active with many of them taking place in Franklin, Texas."
Answered by AI
What medical conditions is PF-07284892 typically used to treat?
"PF-07284892 offers a possible treatment for malignant neoplasms, metastatic melanoma and head and neck squamous cell carcinoma (HNSCC)."
Answered by AI
Are there multiple centers participating in this research endeavor within the city?
"Patients can join this medical trial at Tennessee Oncology PLLC in Franklin,Tennessee Oncology PLLC in Houston, and The University of Texas MD Anderson Cancer Center in Orange. Additionally, there are 8 other sites across the United States that are recruiting participants."
Answered by AI
To what end is this investigation striving?
"This clinical trial's primary aim, measured from baseline to 30 days after study medication is administered, will be the number of participants that experience dose-limiting toxicities (DLTs). Secondary objectives include duration of response, time to reach maximum plasma concentration and its metabolite for both single doses and multiple doses assuming steady states are achieved. Maximum plasma concentrations and their respective metabolites also need to be determined in relation to single or multiple doses as required."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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