A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Pfizer
Summary
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents
Description
Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, 1C, 1D and 1E and Part 2 is divided into Parts 2A, 2B, 2D and 2E. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RDE). In Part 1B, 1C, 1D and 1E PF-07248144 will be administered in combination with either fulvestrant (Part 1B); palbociclib + letrozole (Part 1C) or PF-07220060+fulvestrant (Part 1D) or vepdegestrant (Part 1E). After the determination of the monoth…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Disease Characteristics - Breast, Prostate, and Lung Cancer * Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available. * Part 1B, Part 1C, Part 1D and Part 1E (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy…
Interventions
- DrugPF-07248144
KAT6 Inhibitor
- DrugFulvestrant
Endocrine Therapy
- DrugLetrozole
Endocrine Therapy
- DrugPalbociclib
CDK4/6 Inhibitor
- DrugPF-07220060
CDK4 inhibitor
- DrugPF-07850327, ARV-471, vepdegestrant
PROTAC (PROteolysis Targeting Chimera) ER degrader
Locations (44)
- HonorHealthScottsdale, Arizona
- Cedars Sinai Medical CenterLos Angeles, California
- Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, California
- UCSF Medical Center at Mission BaySan Francisco, California
- Smilow Cancer Hospital at Yale - New HavenNew Haven, Connecticut
- Yale-New Haven Hospital- Yale Cancer CenterNew Haven, Connecticut