Not currently recruiting at UCSF

A Study to Learn About the Study Medicine Called PF-07799544 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 Colorectal Cancer Solid Tumor Colorectal Tumor

Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
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) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.

  • In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day.
  • In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933).

Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

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 ADVANCED SOLID TUMORS

Keywords

Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms, Colorectal Cancer, Proto-Oncogene Proteins B-raf, Carcinoma, Non-Small-Cell Lung, Neoplasm by Histologic Type, CRC, MAPK, Thyroid Neoplasms, Non-Small-Cell Lung Carcinoma, Neoplasms, Colorectal Neoplasms, encorafenib

Eligibility

You can join if…

Open to people ages 16 years and up

  • Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
  • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
  • For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma
  • For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
  • For Substudy B and C, measurable disease by RECIST version 1.1
  • For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
  • For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)

You CAN'T join if...

  • Brain metastasis larger than 4 cm
  • History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco 5391959 California 5332921 94143 United States
  • UCSF Medical Center, Investigational Pharmacy not yet accepting patients
    San Francisco 5391959 California 5332921 94158 United States
  • Providence Cancer Institute Franz Clinic accepting new patients
    Portland 5746545 Oregon 5744337 97213 United States
  • Providence Portland Medical Center accepting new patients
    Portland 5746545 Oregon 5744337 97213 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT05538130
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 124 study participants
Last Updated