Trial Title:
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)
NCT ID:
NCT06125522
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
TACTIVE-U
Umbrella study
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 RP2D of ARV-471
when administered in combination with samuraciclib. The decision to escalate the starting
dose level of ARV-471 will be using mTPI-2 decision criteria based on the number of
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.
In addition, the potential drug-drug interaction (DDI) between ARV-471 and samuraciclib
will be evaluated, at the doses selected as recommended dose for expansion (RDE(s)), in a
DDI Assessment Cohort(s)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
vepdegestrant
Description:
Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b
until RP2D determined, cycles lasting 28 days
Arm group label:
ARV-471 in combination with Samuraciclib
Other name:
ARV-471 / PF-07850327
Intervention type:
Drug
Intervention name:
Samuraciclib
Description:
Daily oral dosages of Samuraciclib continuously, dose escalation/de-escalation in Phase
1b until RP2D determined, cycles lasting 28 days
Arm group label:
ARV-471 in combination with Samuraciclib
Summary:
The purpose of this study is to learn about the safety and effects of the study medicine
called vepdegestrant. The safety and effects of vepdegestrant will be see when given with
other medicines. 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.
This study is divided into separate sub-studies.
For Sub-Study C:
All the participants will receive vepdegestrant and a medicine called samuraciclib.
Vepdegestrant and samuraciclib will be taken once in a day 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 medicine is safe and effective.
Participant will continue to take vepdegestrant and samuraciclib 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:
C4891024 is a prospective, open-label, multicenter, Phase 1b/2 sub-study to evaluate the
safety, antitumor activity, and PK of ARV-471 with samuraciclib in the treatment of
participants with A/MBC. The sub-study is part of Umbrella platform, TACTIVE-U,
comprising multiple sub-studies that independently evaluate ARV-471 in participants with
Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-)
Advanced or Metastatic Breast Cancer. ARV-471 will act as the backbone therapy given in
combination with other anticancer agents thought to have clinical relevance in ER+ breast
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histological or cytological diagnosis of breast cancer. At time of enrollment this
must not be amendable 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: up to 2 lines of prior therapies for advanced/metastatic
disease; 1 line of any CDK4/6 inhibitor-based regimen is required (in any setting eg
adjuvant, metastatic)
- at least 1 measurable lesion as defined by RECIST v1.1.
- ECOG PS ≤1.
Exclusion Criteria:
- visceral crisis at risk of life-threatening complications in the short term
- known history of drug-induced pneumonitis or other significant symptomatic
deterioration of lung functions.
- newly diagnosed brain metastases, or symptomatic 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
- impaired cardiovascular function or clinically significant cardiovascular diseases
- concurrent administration of medications, food, or herb supplements that are strong
inhibitors/inducers of CYP3A, strong CYP2D6 inhibitors 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:
Highlands Oncology Group
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group
Address:
City:
Rogers
Zip:
72758
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Beverly Hills Cancer Center
Address:
City:
Beverly Hills
Zip:
90211
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:
Not yet recruiting
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Stanford Cancer Institute - Clinical Trials Office
Address:
City:
Palo Alto
Zip:
94304
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:
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:
06511
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown University Medical Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
MedStar Washington Hospital Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt McKinley Hospital
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Hospital East
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - Shiloh
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - West County
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - North County
Address:
City:
Florissant
Zip:
63031
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes-Jewish Hospital
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - St Peters
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CIUSSS- saguenay-Lac-Saint-Jean
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Status:
Recruiting
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Régional du Cancer Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
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:
Not yet recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Start date:
January 10, 2024
Completion date:
January 25, 2027
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Arvinas Estrogen Receptor, Inc.
Agency class:
Industry
Collaborator:
Agency:
Carrick Therapeutics Limited
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/NCT06125522
https://pmiform.com/clinical-trial-info-request?StudyID=C4891024
