NCT05963997

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2023

Typical duration for phase_1

Geographic Reach
4 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

June 30, 2023

Last Update Submit

March 19, 2026

Conditions

Metastatic Breast CancerLocally Advanced Breast CancerBreast Cancer

Keywords

Metastatic Breast CancerAdvanced Breast CancerBreast CancerHR PositiveHER2-Negative

Outcome Measures

Primary Outcomes (2)

  • Phase 1b (Dose-finding)

    Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level. Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results

    From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention

  • Phase 2 (Expansion)

    Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.

    From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

Secondary Outcomes (10)

  • Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)

    From the date of first dose of any study intervention through 28 days after the last dose of any study intervention

  • Clinical Benefit Response (CBR)

    From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)

  • Overall response rate (ORR)

    the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

  • Duration of Response (DOR)

    From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

  • Best percent change in tumor size.

    From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

  • +5 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).

Drug: SamuraciclibDrug: Elacestrant Dihydrochloride

Cohort 2

EXPERIMENTAL

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Drug: SamuraciclibDrug: Elacestrant Dihydrochloride

Cohort 3

EXPERIMENTAL

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Drug: SamuraciclibDrug: Elacestrant Dihydrochloride

Cohort 4 Expansion

EXPERIMENTAL

Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Drug: SamuraciclibDrug: Elacestrant Dihydrochloride

Interventions

SamuraciclibDRUG

Samuraciclib capsules by mouth once a day

Cohort 1Cohort 2Cohort 3Cohort 4 Expansion
Elacestrant DihydrochlorideDRUG

Elacestrant tablets by mouth once a day

Also known as: ORSERDU
Cohort 1Cohort 2Cohort 3Cohort 4 Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University

Chicago, Illinois, 60611, United States

Location

Site 42 - Dana-Farber Cancer Institute, EDDC

Boston, Massachusetts, 02215, United States

Location

Site 35 - Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, 44106, United States

Location

Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology

San Antonio, Texas, 78229, United States

Location

Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus

Seattle, Washington, 98122, United States

Location

Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie

Bordeaux, France

Location

Site 80 - Centre Jean Bernard, Clinique Victor Hugo

Le Mans, France

Location

Site 83 - Institut Paoli Calmettes (IPC)

Marseille, France

Location

Site 85 - Institut Curie

Paris, France

Location

Site 82 - Institut de Cancerologie de Ouest (ICO)

Saint-Herblain, France

Location

Site 65 - Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, Spain

Location

Site 68 -Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location

L'Hospitalet de Llobregat, Spain

Location

Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)

Madrid, Spain

Location

Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro

Madrid, Spain

Location

Site 66 - Hospital Clinico San Carlos

Madrid, Spain

Location

Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)

Pamplona, Spain

Location

Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Spain

Location

Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena

Seville, Spain

Location

Site 12 - Belfast City Hospital

Belfast, United Kingdom

Location

Site 4 - The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RAD1901

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 27, 2023

Study Start

October 9, 2023

Primary Completion

March 6, 2026

Study Completion

March 6, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

FR(5)US(5)GB(3)ES(10)