A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in … (NCT05538130) | Clinical Trial Compass
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
United States, Australia, Brazil124 participantsStarted 2022-11-30
Plain-language summary
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:
* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
* tumor with the mutation (abnormal gene) called "BRAF V600"
* received required prior treatment for cancer per cohort assigned.
All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Who can participate
Age range
16 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.
Phase 1b Inclusion Criteria:
* Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
* Measurable disease by RECIST version 1.1
* Evidence of a BRAF V600 mutation
* Prior therapy per tumor cohort
* Adequate organ function per protocol
Phase 1b Exclusion Criteria:
* Other active malignancy within 3 years
* Presence of leptomeningeal disease
* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
* Active gastrointestinal disease as defined per protocol
* History of interstitial lung disease as defined per protocol
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.
1Since this is a Phase 1 trial focused on finding a safe dose of PF-07799544, what is currently known about its safety profile, and how does that uncertainty compare to the standard treatment options available for my specific cancer type?
2The trial is measuring dose-limiting toxicities and adverse events as its main goals — what kinds of side effects have been seen so far, and how would my care team monitor and manage them if I were to participate?
3This study includes people with several different cancer types like melanoma, glioma, NSCLC, and thyroid cancer — do you think my particular diagnosis and any prior treatments I've had would make me a realistic candidate to discuss with the trial team?
4The trial has both a monotherapy phase and a combination treatment phase — is it worth asking the trial team which part of the study I might be considered for, and does the combination arm carry different or additional risks I should understand?
5Given that this is still in the dose-finding stage and the focus is on safety rather than proving the treatment works, would it make more sense for me to try an established standard-of-care therapy first before considering an early-phase trial like this one?
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
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
Timeframe: Cycle 1 (21 days)
2
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
Timeframe: Baseline to 28 days after last dose of study medication
3
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities
Timeframe: Baseline to 28 days after last dose of study treatment
4
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Timeframe: Baseline to 28 days after last dose of study treatment
5
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Timeframe: Baseline to 28 days after last dose of study treatment