polfurmetinib (PF-07799544) / Pfizer - LARVOL DELTA

A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

C4901001: A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=148 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2029 ➔ Aug 2027

Enrollment closed • Monotherapy • Trial completion date • Brain Cancer • Colorectal Cancer • Glioma • High Grade Glioma • Low Grade Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544, plus next-generation BRAF dimer inhibitor, PF-07799933, in advanced BRAF-mutant melanoma. (ASCO 2026) - P1 | "PF-07799544 + PF-07799933 showed manageable safety and promising systemic and IC antitumor activity in heavily pretreated BRAF-mut advanced melanoma. Evaluation of dose expansion cohorts is ongoing."

IO biomarker • Metastases • P1 data • Endocrine Disorders • Melanoma • Nephrology • Renal Disease • Solid Tumor

A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: Pfizer

Combination therapy • New P1 trial • Brain Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: Pfizer | Trial primary completion date: May 2026 ➔ Aug 2026

Combination therapy • Trial primary completion date • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Trial completion date: Mar 2027 ➔ Sep 2028 | Trial primary completion date: Oct 2025 ➔ Mar 2027

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Trial completion date: Dec 2027 ➔ Jun 2027 | Trial primary completion date: Sep 2026 ➔ Jan 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

C4901001: A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Trial completion date: Apr 2029 ➔ Oct 2028 | Trial primary completion date: Oct 2027 ➔ Feb 2027

Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

C4901001: A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Trial completion date: Feb 2029 ➔ Jun 2029

Monotherapy • Trial completion date • Brain Cancer • Colorectal Cancer • Glioma • High Grade Glioma • Low Grade Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

C4901001: A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Pfizer | Trial completion date: Sep 2028 ➔ Aug 2029 | Trial primary completion date: Mar 2027 ➔ Feb 2028

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544 (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: Pfizer

New P1 trial

Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544 (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Pfizer

New P1 trial

Advancing next-generation pipeline of novel mechanisms and differentiated combinations across solid tumors (Businesswire) - "Updated Phase 2 data for PF‑08634404 (PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, as monotherapy in first-line PD-L1-expressing NSCLC...Updated results from a Phase 1 study of sigvotatug vedotin (SV), a novel integrin β6 (IB6)–directed ADC, in combination with pembrolizumab in NSCLC...The first results from a Phase 2 study of neoadjuvant atirmociclib, a highly selective CDK4 inhibitor, in combination with letrozole versus letrozole alone in people with hormone receptor-positive (HR+), HER2- breast cancer....Findings from a Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544 (polfurmetinib), plus a next-generation BRAF inhibitor, PF-07799933 (claturafenib), in advanced BRAF-mutant melanoma."

P1 data • P2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Melanoma • Non Small Cell Lung Cancer

A phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of PF-07799544 (ARRY-134) as a single agent and in combination with PF-07799933 BRAF dimer inhibitor, in participants 16 years and older with advanced solid tumors. (ASCO 2024) - P1 | "Sub-study B: BRAFm melanoma (V600 and non-V600) will determine the MTDc/RDEc of the combination (Part 1 primary objective), followed by dose expansion cohorts (Part 2) (~80 participants): Cohort 1: BRAF V600 melanoma (asymptomatic and untreated bm permitted), Cohort 2: BRAF V600 melanoma (symptomatic bm), Cohort 3 BRAFm Class 2/3 melanoma (asymptomatic and untreated bm permitted); Sub-study C: BRAFm Class 2 or 3 advanced solid tumor Cohort 1 (asymptomatic and untreated bm permitted and Cohort 2 (symptomatic bm) (~20 each cohort). The main objectives of the dose expansion cohorts in all substudies, will be to evaluate anti-tumor activity, safety, PK and PD."

Clinical • Combination therapy • Metastases • P1 data • PK/PD data • Melanoma • Oncology • Solid Tumor