Inhibition of lysine acetyltransferase KAT6 in ER+HER2- metastatic breast cancer: a phase 1 trial.
Toru Mukohara, Yeon Hee Park, David Sommerhalder...
https://pubmed.ncbi.nlm.nih.gov/38824244Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04606446
A Phase 1/2a Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of PF-07248144 in Participants with Advanced or Metastatic Solid Tumors
Led by Pfizer · Updated on 2026-04-16
320
Participants Needed
44
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying PF-07248144, a KAT6 inhibitor, to assess its safety, tolerability, how the body processes it (pharmacokinetics), and its effects (pharmacodynamics) in people with advanced or metastatic solid tumors. The study also looks for early signs that PF-07248144 may work as a treatment, either alone or combined with other drugs. This is an open-label, multi-center trial with several parts for detailed evaluation. The study includes two main phases: Part 1 focuses on dose escalation to find the best dose for PF-07248144 alone and in combination with other drugs like fulvestrant, palbociclib plus letrozole, PF-07220060 with fulvestrant, or vepdegestrant. Part 2 involves dose expansion to further assess PF-07248144 alone or in combination at the recommended doses from Part 1. Different combinations are tested in separate study arms to evaluate their safety and effects. Participants will undergo various assessments including monitoring for side effects and laboratory tests for up to 24 months. Researchers will measure drug levels in the blood, look for dose-limiting toxicities, and evaluate anti-tumor activity such as progression-free survival and overall survival. The study includes detailed safety monitoring and outcome measures to understand how PF-07248144 works and its impact on advanced or metastatic solid tumors.
CONDITIONS
Brief Title
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older (20 years or older in Japan, 19 years or older in South Korea)
- Diagnosis of locally advanced or metastatic ER+ HER2- breast cancer, castration-resistant prostate cancer, or non-small cell lung cancer
- For monotherapy dose escalation: intolerant or resistant to standard therapy or no available standard therapy
- For combination dose escalation: progressed after at least one prior endocrine therapy and CDK4/6 inhibitor for advanced or metastatic ER+ HER2- breast cancer
- For dose expansion: progressed after prior lines of CDK4/6 inhibitor and endocrine therapy as specified per study part
- Documentation of ER-positive tumor with at least 1% positive stained cells and HER2-negative tumor based on local assay
- Female participants of childbearing potential must agree to medically induced menopause or meet postmenopausal criteria
- At least one measurable lesion per RECIST version 1.1 not previously irradiated
- ECOG Performance Status of 0 or 1
- Adequate kidney, liver, and bone marrow function
- Resolved acute effects of prior therapy to baseline or CTCAE Grade 1 except for non-safety risk adverse events
You will not qualify if you...
- Unmanageable ascites (requires sponsor medical monitor review)
- Any other active malignancy within the past 3 years except treated basal or squamous cell skin cancer or carcinoma in situ
- Major surgery, radiation, or systemic anti-cancer therapy within 3 weeks prior to study entry
- Prior irradiation to more than 25% of bone marrow
- Clinically relevant ECG abnormalities such as prolonged QTc, complete LBBB, or AV block
- Therapeutic anticoagulation except low molecular weight heparin; some anticoagulants allowed with sponsor approval
- Known or suspected severe allergy to PF-07248144 or its ingredients
- Active inflammatory gastrointestinal disease or surgeries affecting drug absorption
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months
Participants receive PF-07248144, alone or in combination with other drugs, to evaluate safety, tolerability, and anti-tumor activity.
Regular visits during dose escalation and dose expansion phases
Follow-up
Duration - Up to 24 months
Participants are monitored for safety and treatment effects after stopping the study drug.
Visits as needed for safety assessments
Trial Site Locations
Total: 44 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Terminated
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
5
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
Yale-New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States, 06511
Actively Recruiting
8
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
9
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Terminated
10
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
11
University Medical Center, lnc.:DBA University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
13
UofL Health Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
14
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
MD Anderson The Woodlands
Conroe, Texas, United States, 77384
Actively Recruiting
16
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
U.T. MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
18
MD Anderson West Houston
Houston, Texas, United States, 77079
Actively Recruiting
19
MD Anderson League City
League City, Texas, United States, 77573
Actively Recruiting
20
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
21
MD Anderson
Sugar Land, Texas, United States, 77478
Actively Recruiting
22
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
23
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
24
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Terminated
25
Cancer Research South Australia
Adelaide, South Australia, Australia, 5000
Actively Recruiting
26
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
27
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
28
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, Australia, 3021
Actively Recruiting
29
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
30
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
31
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
32
Jilin Province Tumor Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
33
Jilin Province Tumor Hospital
Changchun, Jilin, China, 132000
Actively Recruiting
34
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
35
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
36
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
37
Kanagawa cancer center
Yokohama, Kanagawa, Japan, 2418515
Actively Recruiting
38
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
39
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
40
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
Actively Recruiting
41
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
Actively Recruiting
42
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
Actively Recruiting
43
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi, South Korea, 41404
Actively Recruiting
44
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
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Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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