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Monoclonal Antibodies
PF-07248144 for Breast Cancer (KAT6 Trial)
Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years)
Participants with ER+HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
KAT6 Trial Summary
This trial is testing a new drug to see if it's safe and effective. It will be given to people with breast cancer who have failed other treatments.
Who is the study for?
Adults with advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC who've exhausted standard treatments. Women must be non-childbearing or agree to induced menopause. Participants need at least one measurable lesion and good organ function but can't join if they have certain GI conditions, recent major surgery, other active cancers (except some skin cancers), are pregnant/breastfeeding, had extensive radiation to the bone marrow, ECG issues, or severe allergies to trial drugs.Check my eligibility
What is being tested?
The study is testing PF-07248144's safety and effectiveness alone and in combination with fulvestrant; letrozole + palbociclib; or PF-07220060 + fulvestrant for treating certain advanced cancers. It's an open-label trial where everyone knows what treatment they're getting and aims to understand how the body processes these drugs.See study design
What are the potential side effects?
Possible side effects include typical reactions related to hormone therapies like hot flashes and joint pain from letrozole/fulvestrant. Palbociclib may cause low blood cell counts leading to infection risk. Side effects of PF-07248144 aren't fully known yet but could involve digestive issues based on its exclusion criteria.
KAT6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old, or 20 if in Japan, or 19 if in South Korea.
Select...
My ER+HER2- breast cancer has worsened after treatment with endocrine therapy and CDK4/6 inhibitor.
Select...
I have a tumor that can be measured and hasn't been treated with radiation.
Select...
I am a woman with advanced breast cancer and I am not able to have children because I am postmenopausal.
Select...
My breast cancer is ER+HER2- and has worsened after treatment with a CDK4/6 inhibitor and hormone therapy.
Select...
I am willing to undergo treatment to stop my periods as part of my breast cancer treatment.
Select...
My ER+HER2- breast cancer has worsened despite treatment with CDK4/6 inhibitors and hormone therapy.
Select...
My breast cancer is ER+ and HER2-.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
KAT6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Upper arm
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms.
Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms
+2 moreSecondary outcome measures
AUC from time zero to time of last measurable concentration (AUClast) in the participants in the food effect subset in monotherapy dose expansion arm
Amount of PF-07248144 excreted in urine relative to dose administered (%) in a sub-set of participants in monotherapy dose expansion arm.
Upper arm
+22 moreKAT6 Trial Design
8Treatment groups
Experimental Treatment
Group I: China Monotherapy Dose ExpansionExperimental Treatment1 Intervention
PF-07248144 Monotherapy Dose Expansion
Group II: 2D Combination Dose Expansion ArmExperimental Treatment3 Interventions
PF-07248144 with PF-07220060 +Fulvestrant Dose Expansion
Group III: 2B Combination Dose Expansion ArmExperimental Treatment2 Interventions
PF-07248144 with Fulvestrant Dose Expansion
Group IV: 2A Monotherapy Dose Expansion ArmExperimental Treatment1 Intervention
PF-07248144 Monotherapy Dose Expansion
Group V: 1D Combination Dose EscalationExperimental Treatment3 Interventions
PF-07248144 with PF-07220060 +Fulvestrant
Group VI: 1C Combination Dose EscalationExperimental Treatment3 Interventions
PF-07248144 with Letrozole + Palbociclib Combination Dose Escalation
Group VII: 1B Combination Dose EscalationExperimental Treatment2 Interventions
PF-07248144 with Fulvestrant Combination Dose Escalation
Group VIII: 1A Monotherapy Dose EscalationExperimental Treatment1 Intervention
PF-07248144 Monotherapy Escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3240
Fulvestrant
2011
Completed Phase 3
~3690
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,799 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,995 Total Patients Enrolled
43 Trials studying Breast Cancer
12,808 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have important irregularities in your heart's electrical activity as shown on an ECG.I have no ongoing severe gut issues or surgeries that could affect medicine absorption.I have severe fluid buildup in my abdomen that can't be controlled.My ER+HER2- breast cancer has worsened after treatment with endocrine therapy and CDK4/6 inhibitor.I have a tumor that can be measured and hasn't been treated with radiation.My kidney, liver, and bone marrow are functioning well.I am a woman with advanced breast cancer and I am not able to have children because I am postmenopausal.My breast cancer is ER+HER2- and has worsened after treatment with a CDK4/6 inhibitor and hormone therapy.I have recovered from the side effects of my previous treatments, except for minor ones.I am at least 18 years old, or 20 if in Japan, or 19 if in South Korea.I am willing to undergo treatment to stop my periods as part of my breast cancer treatment.My ER+HER2- breast cancer has worsened despite treatment with CDK4/6 inhibitors and hormone therapy.I have not had major surgery, radiation, or cancer treatment in the last 3 weeks.My cancer is advanced, does not respond to standard treatments, or there are no treatments available.My breast cancer is ER+ and HER2- with at least 1% of cells ER-positive.More than a quarter of my bone marrow has been exposed to radiation.I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.I am on blood thinners for treatment.You are allergic to the main ingredient or other ingredients in PF-07248144.My breast cancer is ER+ and HER2-.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: 1D Combination Dose Escalation
- Group 2: 1A Monotherapy Dose Escalation
- Group 3: 1C Combination Dose Escalation
- Group 4: 2D Combination Dose Expansion Arm
- Group 5: China Monotherapy Dose Expansion
- Group 6: 1B Combination Dose Escalation
- Group 7: 2B Combination Dose Expansion Arm
- Group 8: 2A Monotherapy Dose Expansion Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA issued a green light for PF-07248144?
"Owing to its experimental nature, PF-07248144 attained a score of 1 as there is only limited data verifying its efficacy and safety."
Answered by AI
Is recruitment ongoing for this research?
"Affirmative. Details found on clinicaltrials.gov confirms that patients are presently being recruited for this medical study, which was initially posted on November 16th 2020 and updated lastly on October 10th 2022. Approximately 108 individuals need to be chosen from 30 separate treatment sites."
Answered by AI
Is there additional research concerning PF-07248144 that has been conducted?
"Presently, 334 studies are underway for PF-07248144 with 68 of these trials in their final phase. Shanghai houses several of the clinical sites investigating this drug; however, there exists a total of 18656 research locations that have trial data available."
Answered by AI
At how many distinct facilities is this experiment taking place?
"Patients are being recruited for this trial from 30 different recruiting sites such as Sarah Cannon Research Institute in Nashville, University Medical Center, lnc.:DBA University of Louisville Hospital in Louisville, and TJU Research PK/PD Lab in Philadelphia."
Answered by AI
What is the participant size for this experiment?
"The current trial necessitates the participation of 108 compliant patients. The Sarah Cannon Research Institute in Nashville, TN and University Medical Center, lnc.:DBA University of Louisville Hospital in Louisville, KY are two of many sites where participants can register for this medical study."
Answered by AI
What medical conditions can PF-07248144 effectively address?
"PF-07248144 is regularly used to tackle the advancement of disease. It can also help ameliorate effects associated with tamoxifen, postmenopause, and advance directives."
Answered by AI
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