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Study of PF-07248144 in Advanced or Metastatic Solid Tumors
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 either fulvestrant or letrozole + palbociclib or with PF-07220060 + fulvestrant.
Study details:
Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, 1C and 1D and Part 2 is divided into Parts 2A, 2B and 2D. 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 and 1D, PF-07248144 will be administered in combination with either fulvestrant (Part 1B); palbociclib + letrozole (Part 1C) or PF-07220060+fulvestrant (Part 1D). . After the determination of the monotherapy RDE in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A.
After determination of the combination RDE from Part 1B, PF-07248144 in combination with fulvestrant, PF-07248144 will be evaluated in a combination dose expansion with fulvestrant in Part 2B. In Part 1C, PF-07248144 in combination with letrozole + palbociclib will be evaluated for dose finding to determine the MTD and RDE for this combination. After determination of the triple combination RDE from Part 1D, PF-07248144 in combination with PF-07220060 + fulvestrant will be evaluated in a combination dose-expansion cohort, Part 2D.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-11-16
Primary completion: 2025-05-09
Study completion finish: 2026-11-08
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04606446
Intervention or treatment
DRUG: PF-07248144
DRUG: Fulvestrant
DRUG: Letrozole
DRUG: Palbociclib
DRUG: PF-07220060
Conditions
- • Locally Advanced or Metastatic ER+ HER2- Breast Cancer
- • Locally Advanced or Metastatic Castration-resistant Prostate Cancer
- • Locally Advanced or Metastatic Non-small Cell Lung Cancer
Find a site
Closest Location:
Chris O'Brien Lifehouse
Research sites nearby
Select from list below to view details:
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 1A Monotherapy Dose Escalation
| DRUG: PF-07248144
|
EXPERIMENTAL: 1B Combination Dose Escalation
| DRUG: PF-07248144
|
EXPERIMENTAL: 1C Combination Dose Escalation
| DRUG: PF-07248144
|
EXPERIMENTAL: 2A Monotherapy Dose Expansion Arm
| DRUG: PF-07248144
|
EXPERIMENTAL: 2B Combination Dose Expansion Arm
| DRUG: PF-07248144
|
EXPERIMENTAL: 1D Combination Dose Escalation
| DRUG: PF-07248144
|
EXPERIMENTAL: 2D Combination Dose Expansion Arm
| DRUG: PF-07248144
|
EXPERIMENTAL: China Monotherapy Dose Expansion
| DRUG: PF-07248144
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with dose-limiting toxicities in the Dose Escalation Arms. | Dose-limiting toxicities (DLTs) | Up to 29 days |
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms. | Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy. | Up to 24 months |
Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms. | Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. | Up to 24 months |
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms | Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy. | Up to 24 months |
Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion Arms | Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. | Up to 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Single Dose: Maximum Observed Concentration (Cmax) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Single Dose: Time to Maximum concentration (Tmax) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Single Dose: AUC from time zero to time of last measurable concentration (AUClast) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Single and Multiple Dose: Terminal Elimination half-life (t1/2) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Multiple Dose: Steady-State Cmax (Cmax,ss) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Multiple Dose: Steady-state Tmax (Tmax,ss) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Multiple Dose: Steady state AUC during a dosage interval (τ) (AUCτ,ss) in the Dose Escalation and Dose Finding Arms | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Multiple Dose: Steady-state Cmin (Cmin,ss) in the Dose Escalation and Dose Finding Arms. | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Multiple Dose: Steady-state apparent total clearance (CLss/F) in the Dose Escalation and Dose Finding Arms. | Pharmacokinetic (PK) assessments for PF-07248144 and PF-07220060 (Part 1D) | Up to 24 months |
Palbociclib trough concentrations at steady instate (Cmin,ss) in the 1C combination dose finding arm. | Pharmacokinetic (PK) assessment for palbociclib exposure. | Up to 24 months |
Best Overall Response (BOR) in participants in the Dose Expansion Arms | Not Specified | Up to 24 months |
Duration of Response (DOR) in participants enrolled in the Dose Expansion Arms | Not Specified | Up to 24 months |
Peak concentrations of PF-07248144 and PF-07220060 (Part 2D) for selected cycles in the Dose Expansion Arms | Pharmacokinetic (PK) assessment for PF-07248144 and PF-07220060 (Part 2D) | Up to 24 months |
Trough concentrations of PF-07248144 for selected cycles in the Dose Expansion Arms | Pharmacokinetic (PK) assessment for PF-07248144 and PF-07220060 (Part 2D) | Up to 24 months |
Maximum Observed Concentration (Cmax) in the participants in the food effect subset in monotherapy dose expansion arm | The effect of food on the PK of PF-07248144. | Cycle 1 Day -7 and Cycle 1 Day 1 (each cycle is 28 days) |
Time to Maximum concentration (Tmax) in the participants in the food effect subset in monotherapy dose expansion arm | The effect of food on the PK of PF-07248144. | Cycle 1 Day -7 and Cycle 1 Day 1 (each cycle is 28 days) |
AUC from time zero to time of last measurable concentration (AUClast) in the participants in the food effect subset in monotherapy dose expansion arm | The effect of food on the PK of PF 07248144. | Cycle 1 Day -7 and Cycle 1 Day 1 (each cycle is 28 days) |
Amount of PF-07248144 excreted in urine relative to dose administered (%) in a sub-set of participants in monotherapy dose expansion arm. | Evaluate urine pharmacokinetic (PK) of PF-07248144. | Up to 24 months |
Renal clearance (CLr) in a sub-set of participants in monotherapy dose expansion arm | Evaluate urine pharmacokinetic (PK) of PF-07248144. | Up to 24 months |
Progression Free Survival (PFS) observed in participants in the Dose Expansion Arms | Not Specified | Up to 24 months |
Time to Progression (TTP) observed in participants enrolled in the Dose Expansion Arms | Not Specified | Up to 24 months |
Overall survival (OS) observed in participants enrolled in Dose Expansion Arms | Not Specified | Up to 24 months |
Best Overall Response (BOR) observed in participants in the dose expansion arms | Not Specified | Up to 24 months |
Duration of Response (DOR) observed in participants in the dose expansion arms | Not Specified | up to 24 months |
Clinical Benefit Rate (CBR) observed in participants in the Dose Expansion Arms | Not Specified | up to 24 months |
Frequently Asked Questions
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