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PF-07799544 / Glioma / PF-07799933 · Phase 1 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing Phase 1 clinical trial of PF-07799544 as monotherapy and in combination with PF-07799933 for advanced solid tumors. No results are posted; the record describes the planned study design, enrollment target, and primary outcome measures focused on safety and dose-limiting toxicities in Phase 1a and 1b, with overall response rate assessed in Phase 1b expansion.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms, Advanced or Metastatic Solid Tumors, HGG, LGG, Low Grade Gl…; age from 16 Years. Intervention: Phase 1a Monotherapy Dose Escalation; Phase 1b Combination Dose Escalation; Phase 1b Combination Dose Expansion. n = 124. 83 sites across 7 countries.
This is a registry record for an ongoing Phase 1 clinical trial of PF-07799544 as monotherapy and in combination with PF-07799933 for advanced solid tumors. No results are posted; the record describes the planned study design, enrollment target, and primary outcome measures focused on safety and dose-limiting toxicities in Phase 1a and 1b, with overall response rate assessed in Phase 1b expansion.
Phase 1 design focuses on safety and dose escalation; efficacy data (ORR) from expansion phase not yet available.
No clinical impact can be assessed from this registry record, as no efficacy or safety results are posted. Clinicians and researchers should monitor for publication of results once Phase 1b dose escalation and expansion are complete.
Phase 1 dose escalation and expansion trial with no results posted; registry record describes planned safety and efficacy assessment in advanced solid tumors but contains no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no efficacy or safety results are posted. Clinicians and researchers should monitor for publication of results once Phase 1b dose escalation and expansion are complete.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05538130). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 124 participants (ESTIMATED). Conditions: Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms, Advanced or Metastatic Solid Tumors, HGG, LGG, Low Grade Glioma, High Grade Glioma, Differentiated Thyroid Cancer, NSCLC (Non-small Cell Lung Cancer). Interventions: DRUG: PF-07799544; DRUG: PF-07799933. Primary outcome measures: Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) , Cycle 1 (21 days); Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs) , Baseline to 28 days after last dose of study medication; Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities , Baseline to 28 days after last dose of study treatment; Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities , Baseline to 28 days after last dose of study treatment; Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities , Baseline to 28 days after last dose of study treatment; Phase 1b Dose Expansion: Overall response rate (ORR) , Baseline to 2 years. Brief 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.
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