Trial Title:
A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
NCT ID:
NCT06206837
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Proteolysis Targeting Chimera (PROTAC)
metastatic breast cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1b will use an escalation/de-escalation approach to determine the recommended phase
2 dose (RP2D) of vepdegestrant when administered in combination with PF-07220060. The
decision to escalate the starting dose level of vepdegestrant will be using mTPI-2
decision criteria based on the number of dose limiting toxicity (DLT)-evaluable
participants and the number of DLTs in those participants during the DLT observation
period (Cycle 1).
Phase 2 will further evaluate the preliminary antitumor activity and safety of the
combination RP2D.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
vepdegestrant
Description:
Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase
1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
Arm group label:
vepdegestrant in combination with PF-07220060
Other name:
ARV-471 / PF07850327
Intervention type:
Drug
Intervention name:
PF-07220060
Description:
Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b
until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
Arm group label:
vepdegestrant in combination with PF-07220060
Summary:
The purpose of this study is to learn about the safety and effects of giving
vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a
possible treatment for advanced metastatic breast cancer. This type of cancer would have
spread from where it started (breast) to other parts of the body and would be tough to
treat. The study is seeking for participants who have breast cancer that:
- is hard to treat (advanced) and may have spread to other organs (metastatic).
- is sensitive to hormonal therapy (it is called estrogen receptor positive).
- is no longer responding to treatments taken before starting this study.
All the participants will receive vepdegestrant and PF-07220060. Both medicines will be
taken by mouth. The medicines will be taken at home. The experience of people receiving
the study medicines will be studied. This will help see if the study medicines are safe
and effective. Participants will continue to take vepdegestrant and PF-07220060 until:
- their cancer is no longer responding, or
- side effects become too severe. They will have visits at the study clinic about
every 4 weeks.
Detailed description:
C4891026 is a prospective, open-label, multicenter, Phase 1b/2 study to evaluate the
safety, antitumor activity, and pharmacokinetic (PK) of vepdegestrant in combination with
PF-07220060 in the treatment of participants with Estrogen Receptor Positive/Human
Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Advanced or Metastatic Breast
Cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histological or cytological diagnosis of breast cancer. At time of enrollment this
must not be amenable to surgical resection with curative intent (≥1% ER+ stained
cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or
in-situ hybridization per ASCO/CAP).
- prior anticancer therapies: Phase 1b: at least 1 line of SOC for A/MBC; Prior
fulvestrant allowed; ≤1 prior chemotherapy line (no antibody-drug conjugates
permitted) for A/MBC setting allowed. Phase 2: At least one and maximum 2 lines of
ET in A/MBC setting and most recent ET-based regimen for >6 months.
1, and only 1, prior CDK4/6 inhibitor-based regimen required. Up to 1 prior regimen
of cytotoxic chemotherapy (no antibody-drug conjugates permitted) in the A/MBC
setting; Prior fulvestrant allowed.
- Participant with only non-measurable lesion (Phase1b) or at least 1 measurable
lesion as defined by RECIST v1.1. (Phase2) are eligible.
- ECOG PS = 0 or 1 (Phase1b) ; ≤2 (Phase2)
Exclusion Criteria:
- visceral crisis at risk of life-threatening complications in the short term.
- Any condition precluding an adeguate absorption of study interventions.
- newly diagnosed brain metastases, or symptomatic central nervous system (CNS)
metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a
history of CNS metastases or cord compression are eligible if they have been
definitively treated, clinically stable and discontinued anti-seizure medications
and corticosteroids for at least 28 days prior to enrollment in the of study.
- history of any other tumor malignancies within the past 3 years, except for the
following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2)
curatively treated in situ carcinoma of the cervix. Inflammatory breast cancer are
excluded
- impaired cardiovascular function or clinically significant cardiovascular diseases.
- concurrent administration of medications, food, or herb supplements that are strong
inhibitors/inducers of CYP3A or UGT2B7, moderate inducers of CYP34 (Phase1b only)
and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
- renal impairment, not adequate liver function and/or bone marrow function.
- known active infection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hoag Health Center Irvine
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Hoag Hospital Irvine
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Clinical and Translational Research Unit (CTRU)
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Institute - Clinical Trials Office
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Medical Center at Mission Bay
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UCHealth Poudre Valley Hospital
Address:
City:
Fort Collins
Zip:
80524
Country:
United States
Status:
Recruiting
Facility:
Name:
UCHealth Harmony
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UCHealth Harmony
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Facility:
Name:
UCHealth Greeley Hospital
Address:
City:
Greeley
Zip:
80634
Country:
United States
Status:
Recruiting
Facility:
Name:
UCHealth - Medical Center of the Rockies
Address:
City:
Loveland
Zip:
80538
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Hospital - Yale New Haven Health
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale - New Haven Hospital - Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Hospital Phase 1 Unit
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Hospital - Trumbull
Address:
City:
Trumbull
Zip:
06611
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Facility:
Name:
Rockefeller Outpatient Pavilion (53rd Street)
Address:
City:
New York
Zip:
10022
Country:
United States
Status:
Recruiting
Facility:
Name:
Evelyn H. Lauder Breast and Imaging Center (BAIC).
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Grand Hôpital de Charleroi
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
AZ Groeninge Campus Kennedylaan
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Meizhou People's Hospital
Address:
City:
Meizhou
Zip:
514031
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Wuhan Union Hospital Cancer Center
Address:
City:
Wuhan
Zip:
430023
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jilin Province Tumor Hospital
Address:
City:
Changchun
Zip:
132000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Institut Régional du Cancer Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Not yet recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa cancer center
Address:
City:
Yokohama
Zip:
2418515
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Showa University Hospital
Address:
City:
Shinagawa
Zip:
142-8666
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
BRCR Global - Mayaguez Administrative Office
Address:
City:
Mayaguez
Zip:
00680
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
BRCR Global - Mayagüez
Address:
City:
Mayaguez
Zip:
00682
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Arnau de Vilanova de Lleida
Address:
City:
Lleida
Zip:
25198
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Nieves
Address:
City:
Granada
Zip:
18012
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Start date:
February 19, 2024
Completion date:
February 13, 2026
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Arvinas Estrogen Receptor, Inc.
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06206837
https://pmiform.com/clinical-trial-info-request?StudyID=C4891026
