Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Pfizer
Study ID
NCT04606446
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic Castration-resistant Prostate Cancer
  • Locally Advanced or Metastatic ER+ HER2- Breast Cancer
  • Locally Advanced or Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-07248144 — DRUG
    KAT6 Inhibitor
  • Fulvestrant — DRUG
    Endocrine Therapy
  • Letrozole — DRUG
    Endocrine Therapy
  • Palbociclib — DRUG
    CDK4/6 Inhibitor
  • PF-07220060 — DRUG
    CDK4 inhibitor
  • PF-07850327, ARV-471, vepdegestrant — DRUG
    PROTAC (PROteolysis Targeting Chimera) ER degrader

Study Details

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

Key Dates

Start date
Nov 16, 2020
Status verified
Apr 2026
Primary completion
Jul 13, 2029
Completion
Aug 10, 2029

Study Design

Enrollment
320 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1A Monotherapy Dose Escalation
    PF-07248144 Monotherapy Escalation
  • Experimental: 1B Combination Dose Escalation
    PF-07248144 with Fulvestrant Combination Dose Escalation
  • Experimental: 1C Combination Dose Escalation
    PF-07248144 with Letrozole + Palbociclib Combination Dose Escalation
  • Experimental: 2A Monotherapy Dose Expansion Arm
    PF-07248144 Monotherapy Dose Expansion
  • Experimental: 2B Combination Dose Expansion Arm
    PF-07248144 with Fulvestrant Dose Expansion
  • Experimental: 1D Combination Dose Escalation
    PF-07248144 with PF-07220060 +Fulvestrant
  • Experimental: 2D Combination Dose Expansion Arm
    PF-07248144 with PF-07220060 +Fulvestrant Dose Expansion
  • Experimental: China Monotherapy Dose Expansion
    PF-07248144 Monotherapy Dose Expansion
  • Experimental: 1E Combination Dose Escalation
    PF-07248144 with Vepdegestrant Combination Dose Escalation
  • Experimental: 2E Combination Dose Expansion Arm
    PF-07248144 with Vepdegestrant Combination Dose Expansion

Primary Outcome Measure

Number of participants with dose-limiting toxicities in the Dose Escalation Arms. [ Time Frame: Up to 29 days ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158-
Smilow Cancer Hospital at Yale - New HavenNew HavenConnecticut06510-
Smilow Cancer Hospital Phase 1 UnitNew HavenConnecticut06511-
Yale UniversityNew HavenConnecticut06511-
Yale-New Haven Hospital- Yale Cancer CenterNew HavenConnecticut06510-
Holy Cross HospitalFort LauderdaleFlorida33308-
St. Elizabeth HealthcareEdgewoodKentucky41017-
University Medical Center, lnc.:DBA University of Louisville HospitalLouisvilleKentucky40202-
University of LouisvilleLouisvilleKentucky40202-
UofL Health Brown Cancer CenterLouisvilleKentucky40202-
SCRI Oncology PartnersNashvilleTennessee37203-
MD Anderson The WoodlandsConroeTexas77384-
MD Anderson West HoustonHoustonTexas77079-
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
U.T. MD Anderson Cancer CenterHoustonTexas77030-
MD Anderson League CityLeague CityTexas77573-
NEXT OncologySan AntonioTexas78229-
MD AndersonSugar LandTexas77478-
Swedish Cancer InstituteSeattleWashington98104-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth· Scottsdale, AZCedars Sinai Medical Center· Los Angeles, CACedars-Sinai Cancer at Cedars-Sinai Medical Center· Los Angeles, CAUCSF Medical Center at Mission Bay· San Francisco, CASmilow Cancer Hospital at Yale - New Haven· New Haven, CTSmilow Cancer Hospital Phase 1 Unit· New Haven, CT

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