A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

a study on Skin Cancer/Melanoma Glioma Thyroid Cancer Lung Cancer Non-Small Cell Lung Cancer Malignant Neoplasm Neoplasms Brain Cancer Brain Tumor Solid Tumor HGG LGG

Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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.

Official Title

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

Keywords

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), solid tumors, BRAF, advanced solid tumors, B-Raf, MAPK, neoplasms, BRAF V600, Thyroid Neoplasms, Non-Small-Cell Lung Carcinoma

Eligibility

For people ages 16 years and up

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

Locations

  • UCSF Helen Diller Medical Center at Parnassus Heights accepting new patients
    San Francisco California 94143 United States
  • UCSF Medical Center, Investigational Pharmacy accepting new patients
    San Francisco California 94158 United States
  • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) accepting new patients
    Santa Monica California 90404 United States
  • The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate accepting new patients
    Los Angeles California 90025 United States
  • Keck Hospital of USC not yet accepting patients
    Los Angeles California 90033 United States
  • Los Angeles General Medical Center not yet accepting patients
    Los Angeles California 90033 United States
  • USC/Norris Comprehensive Cancer Center not yet accepting patients
    Los Angeles California 90033 United States
  • Keck Medical Center of USC Pasadena not yet accepting patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT05538130
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 124 study participants
Last Updated
Contact us about this trial