Trial Title:
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
NCT ID:
NCT05963997
Condition:
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Metastatic Breast Cancer
Advanced Breast Cancer
Breast Cancer
HR Positive
HER2-Negative
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Samuraciclib
Description:
Samuraciclib capsules by mouth once a day
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4 Expansion
Intervention type:
Drug
Intervention name:
Elacestrant Dihydrochloride
Description:
Elacestrant tablets by mouth once a day
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4 Expansion
Other name:
ORSERDU
Summary:
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and
efficacy of samuraciclib in combination with elacestrant in adult participants with
metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth
Factor Receptor (HER)2-negative breast cancer.
Detailed description:
This is a multiple cohort study, an initial dose escalation phase is designed to confirm
the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee
(SRC) will monitor the safety, tolerability, and PK data during this phase. Once
ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib
in combination with elacestrant.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or
metastatic breast cancer.
- Documented objective disease progression while on or within 6 months after the end
of the most recent therapy.
- Received prior AI in combination with a CDK4/6i as the last therapy
- Known TP53 and ESR1 mutation status.
- Participants must have measurable disease or bone only disease as defined by
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pre/peri-menopausal participants must have commenced treatment with a luteinizing
hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of
study intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no
deterioration over the past 2 weeks.
- Expected life expectancy of >12 weeks in the judgement of the treating investigator.
Exclusion Criteria:
- Inflammatory breast cancer.
- Participants with any other active malignancy within 3 years prior to enrollment,
except for adequately treated basal cell or squamous cell skin cancer, or carcinoma
in situ of the cervix.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease
treatment.
- Inadequate hepatic, renal, and bone marrow function.
- Clinically significant cardiovascular disease.
- Any current or prior central nervous system metastases, carcinomatous meningitis, or
leptomeningeal disease.
- Pregnant or breastfeeding women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Site 42 - Dana-Farber Cancer Institute, EDDC
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Site 35 - Cleveland Clinic, Taussig Cancer Institute
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Address:
City:
Seattle
Zip:
98122
Country:
United States
Facility:
Name:
Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Facility:
Name:
Site 80 - Centre Jean Bernard, Clinique Victor Hugo
Address:
City:
Le Mans
Country:
France
Facility:
Name:
Site 83 - Institut Paoli Calmettes (IPC)
Address:
City:
Marseille
Country:
France
Facility:
Name:
Site 85 - Institut Curie
Address:
City:
Paris
Country:
France
Facility:
Name:
Site 82 - Institut de Cancerologie de Ouest (ICO)
Address:
City:
Saint-Herblain
Country:
France
Facility:
Name:
Site 65 - Complexo Hospitalario Universitario A Coruña
Address:
City:
A Coruña
Country:
Spain
Facility:
Name:
Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Site 68 -Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location
Address:
City:
L'Hospitalet De Llobregat
Country:
Spain
Facility:
Name:
Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)
Address:
City:
Madrid
Country:
Spain
Facility:
Name:
Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro
Address:
City:
Madrid
Country:
Spain
Facility:
Name:
Site 66 - Hospital Clinico San Carlos
Address:
City:
Madrid
Country:
Spain
Facility:
Name:
Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Address:
City:
Pamplona
Country:
Spain
Facility:
Name:
Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid
Address:
City:
Pozuelo de Alarcon
Country:
Spain
Facility:
Name:
Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Country:
Spain
Facility:
Name:
Site 12 - Belfast City Hospital
Address:
City:
Belfast
Country:
United Kingdom
Facility:
Name:
Site 4 - The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Facility:
Name:
Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Start date:
October 9, 2023
Completion date:
June 16, 2025
Lead sponsor:
Agency:
Carrick Therapeutics Limited
Agency class:
Industry
Collaborator:
Agency:
Berlin-Chemie AG Menarini Group
Agency class:
Industry
Source:
Carrick Therapeutics Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963997
