At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 320 target
Drug / intervention
PF-07248144 +5 moredrug
Likely dose
Not stated in record
Key inclusion· 13
- ✓Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer
- ✓Part 1A: intolerant or resistant to standard therapy or no standard therapy available
- ✓Part 1B-1E: progressed after at least 1 prior line of endocrine therapy and CDK4/6 inhibitor
- ✓Part 2A: progressed after at least 1 prior line CDK4/6 inhibitor and endocrine therapy
Key exclusion· 9
- ✕Unmanageable ascites
- ✕Any other active malignancy within 3 years except basal cell/squamous cell skin cancer or carcinoma in situ
- ✕Major surgery, radiation, or systemic anti-cancer therapy within 3 weeks
- ✕Prior irradiation to >25% of bone marrow
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PF-07248144, Fulvestrant, and 4 other interventions for Locally Advanced or Metastatic ER+ HER2- Breast Cancer and 2 related conditions. Currently recruiting, targeting 320 participants across 44 sites in 5 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
CountriesAustralia, China, Japan, South Korea, United States
Collaborators--
Timeline
Phase 2Recruiting
202120222023202420252026202720282029
First PostedOct 2020
Enrollment StartNov 2020
TodayJul 2026
Primary CompletionJul 2029
Study CompletionAug 2029
First PostedOct 28, 2020
Enrollment StartNov 16, 2020
Primary CompletionJul 13, 2029
Study CompletionAug 10, 2029
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 5.7 years agoPrimary completion in 3.0 years
Interventions
PF-07248144drug
KAT6 Inhibitor
Fulvestrantdrug
Endocrine Therapy
Letrozoledrug
Endocrine Therapy
Palbociclibdrug
CDK4/6 Inhibitor
PF-07220060drug
CDK4 inhibitor
PF-07850327, ARV-471, vepdegestrantdrug
PROTAC (PROteolysis Targeting Chimera) ER degrader