Phase 1/2a Dose Escalation, Finding and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy

UVA Tracking #
HSR220100
Principal Investigator
Patrick M Dillon
Contact
Contact Phone
Official Trial Title
Phase 1/2a Dose Escalation, Finding and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have an advanced type of breast cancer known as Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2-) negative advanced or metastatic breast cancer (MBC) or small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) or advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC). This study will explore the safety of an investigational drug known as PF 07104091 as well as your body’s response to PF-07104091 as a single agent, or in combination with fulvestrant or in combination with palbociclib and fulvestrant, or in combination with palbociclib and letrozole.

The total length of treatment is approximately 6 months, but could be longer if you are continuing to benefit from the study. You will be assigned to receive the study drug, PF 07104091 as a single agent or in combination, and your study doctor will let you know which study treatment you will receive. If you are assigned to be receive combination study treatment, you will receive PF-07104091 in combination with an endocrine study therapy (fulvestrant) or in combination with palbociclib and fulvestrant, or in combination with palbociclib and letrozole in this study. This study will require you to visit the study doctor weekly for the first two months and once a month for the remainder of the study (with the exception of the first six months of study where you will have to come every eight weeks and then every twelve weeks afterwards up to two years) to undergo study procedures and to provide information about your health.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04553133

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation