PF-07284892 in Participants With Advanced Solid Tumors (NCT04800822) | Clinical Trial Compass
TerminatedPhase 1
PF-07284892 in Participants With Advanced Solid Tumors
Stopped: The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue
United States53 participantsStarted 2021-03-17
Plain-language summary
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years at the time of informed consent
* 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).
* Documentation evidence of biomarker mutation status
* 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).
BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).
RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC (Cohort 7).
Exclusion Criteria:
* Brain metastasis larger than 4 cm
* Active malignancy within 3 years
* Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to start of study treatment. Antibody based agents within 4 weeks prior to start of study treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study treatment.
* For participants who may get lorlatinib or encorafenib on study, history of interstitial lung disease
* For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated early — can you find out why it was stopped, and what that might mean about the safety or effectiveness of PF-07284892 for someone in my situation?
2Since this was a Phase 1 trial focused mainly on finding safe doses and measuring side effects rather than proving the drug works, what do we actually know so far about whether PF-07284892 showed any signs of helping patients with solid tumors?
3The trial was tracking serious things like dose-limiting toxicities and lab abnormalities — based on what's been reported, are there any safety signals from this study I should be aware of before considering anything related to this drug?
4Given that this trial has been terminated, are there other active trials studying similar approaches or targets for my type of solid tumor that might be worth looking into instead?
5Would pursuing a standard treatment option first make more sense for me right now, given that this particular trial is no longer enrolling and the drug was still in very early-stage safety testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1 and Part 2- Number of participants with dose limiting toxicities (DLTs)
Timeframe: Cycle 1 (21 days)
2
Part 1 and Part 2- Number of participants with treatment-emergent adverse events (AEs)
Timeframe: Baseline up to 30 days after last dose of study medication
3
Part 1 and Part 2 - Number of participants with clinically significant change from baseline in laboratory abnormalities
Timeframe: Baseline up to 30 days after last dose of study treatment
4
Part 1 and Part 2 - Number of dose interruptions, dose modifications, and discontinuations due to AEs
Timeframe: Baseline up to 30 days after the last dose of study medication