Clinical trial • Phase I/II • Oncology
RGT-419B for Breast cancer | Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer
Phase I/II trial of RGT-419B for Breast cancer | Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer | Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 05-08-2025
- First CTIS Authorization Date
- 26-11-2025
Trial design
Randomised, open-label, abemaciclib (film-coated tablet) relabeled for clinical trial use; used in combination with giredestrant (dose and schedule not specified in provided record).-controlled, adaptive Phase I/II trial in France, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Abemaciclib (film-coated tablet) relabeled for clinical trial use; used in combination with giredestrant (dose and schedule not specified in provided record).
- Adaptive
- True, Phase Ib includes dose‑finding/dose‑escalation elements to evaluate DLTs and identify recommended dose for Phase II; Phase II compares two dose levels of GDC-4198 in combination with giredestrant.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 212
Eligibility
Recruits 212 paediatric patients.
- Vulnerable Population
- Vulnerable populations selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are available for Newborn, Infant and Pregnant participants (e.g. L1_GO46021_Newborn-ICF_FR, L1_GO46021_Infant_ICF_ES, L1_GO46021_Pregnant-Participant-ICF_FR), indicating consent/assent processes are addressed in the ICF documents.
Inclusion criteria
- {"criterion_text":"- Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced (not amenable to surgical or radiation therapy with curative intent) or metastatic"}
- {"criterion_text":"- Previously documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP; Allison et al. 2020) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines"}
- {"criterion_text":"- Previously documented HER2– tumor according to ASCO/CAP (Wolff et al. 2023) or ESMO guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines"}
- {"criterion_text":"- Disease progression during or after treatment with an approved CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, ribociclib, etc.) and endocrine therapy (ET) in the locally advanced or metastatic setting"}
- {"criterion_text":"- Measurable or non-measurable evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1"}
Exclusion criteria
- {"criterion_text":"- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions [pleural, pericardial, peritoneal] or pulmonary lymphangitis) appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines"}
- {"criterion_text":"- Have received more than one-line of therapy for locally advanced or metastatic disease"}
- {"criterion_text":"- Have received prior chemotherapy for metastatic breast cancer"}
- {"criterion_text":"- Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half‑lives, whichever is shorter, prior to initiation of study drug"}
- {"criterion_text":"- Poor peripheral venous access"}
- {"criterion_text":"- Malabsorption condition (e.g., active inflammatory gastrointestinal (GI) disease, etc.) or other GI conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE v5.0) grading scale","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v5.0"}
- {"endpoint_text":"- Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline"}
- {"endpoint_text":"- Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline"}
- {"endpoint_text":"- Incidence and nature of dose-limiting toxicities (DLTs)","definition_or_measurement_approach":"Incidence and characterization of DLTs as recorded during dose‑limiting evaluation period (DLT definitions not detailed in provided record)"}
- {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"Not specified in the provided record"}
Secondary endpoints
- {"endpoint_text":"- Phase Ib Stage: Overall Response Rate (ORR)","definition_or_measurement_approach":"ORR (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase Ib Stage:Clinical Benefit Rate (CBR)","definition_or_measurement_approach":"CBR (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase Ib Stage:Area under the concentration time-curve from Time 0 to last measurable concentration (AUC0-t), area under the concentration time-curve from Time 0 to infinity (AUCinf), and maximum serum Concentration (Cmax) following administration of a single dose of GDC-4198 under fasted and fed conditions","definition_or_measurement_approach":"Pharmacokinetic parameters AUC0-t, AUCinf, Cmax following single-dose under fed and fasted conditions"}
- {"endpoint_text":"- Phase II Stage: Overall Response Rate (ORR)","definition_or_measurement_approach":"ORR (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase II Stage:Duration of Response (DOR)","definition_or_measurement_approach":"DOR (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase II Stage: Clinical Benefit Rate (CBR)","definition_or_measurement_approach":"CBR (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase II Stage: Overall Survival (OS)","definition_or_measurement_approach":"OS (definition/assessment method not further specified in record)"}
- {"endpoint_text":"- Phase II Stage: OS rate at 6 months and 12 months","definition_or_measurement_approach":"OS rate at specified timepoints (6 and 12 months)"}
- {"endpoint_text":"- Phase II Stage: PFS rate at 6 months and 12 months","definition_or_measurement_approach":"PFS rate at specified timepoints (6 and 12 months)"}
- {"endpoint_text":"- Phase II Stage:Incidence and severity of adverse events, with severity determined according to the CTCAE v5.0 grading scale","definition_or_measurement_approach":"Severity determined according to CTCAE v5.0"}
- {"endpoint_text":"- Phase II Stage: Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline"}
- {"endpoint_text":"- Phase II Stage: Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline"}
- {"endpoint_text":"- Phase II Stage:Plasma concentrations of GDC-4198 and its metabolites at specified timepoints","definition_or_measurement_approach":"Plasma concentration measurements at specified timepoints (PK sampling)"}
- {"endpoint_text":"- Phase II Stage: Relationship between GDC-4198 dose and safety, pharmacokinetics, and efficacy","definition_or_measurement_approach":"Dose–response relationship assessments across safety, PK and efficacy endpoints"}
Recruitment
- Planned Sample Size
- 212
- Recruitment Window Months
- 32
- Consent Approach
- Subject information and informed consent forms are provided; ICFs available in multiple languages (French, German, Italian, Spanish) and include specific ICFs for newborn, infant and pregnant participants (e.g. L1_GO46021_Newborn-ICF_FR, L1_GO46021_Infant_ICF_ES, L1_GO46021_Pregnant-Participant-ICF_FR), indicating age-specific documents are prepared and consent processes are addressed in the ICFs.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 73
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 40
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Chayma Bousrih
- Principal Investigator Email
- Chayma.bousrih@gustaveroussy.fr
- Contact Person Name
- Chayma Bousrih
- Contact Person Email
- Chayma.bousrih@gustaveroussy.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Sarra Lakhdar
- Principal Investigator Email
- s-lakhdar@o-lambret.fr
- Contact Person Name
- Sarra Lakhdar
- Contact Person Email
- s-lakhdar@o-lambret.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- George Emile
- Principal Investigator Email
- g.emile@baclesse.unicancer.fr
- Contact Person Name
- George Emile
- Contact Person Email
- g.emile@baclesse.unicancer.fr
- Site Name
- Institut Godinot
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Pauline Soibinet
- Principal Investigator Email
- Pauline.soibinet@reims.unicancer.fr
- Contact Person Name
- Pauline Soibinet
- Contact Person Email
- Pauline.soibinet@reims.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Fanny Le Du
- Principal Investigator Email
- f.ledu@rennes.unicancer.fr
- Contact Person Name
- Fanny Le Du
- Contact Person Email
- f.ledu@rennes.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 10-11-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 16
- Number Of Sites
- 6
- Number Of Participants
- 17
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department für Frauengesundheit
- Principal Investigator Name
- Léa Louise Volmer
- Principal Investigator Email
- Lea-Louise.Volmer@med.uni-tuebingen.de
- Contact Person Name
- Léa Louise Volmer
- Contact Person Email
- Lea-Louise.Volmer@med.uni-tuebingen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Universitäres Brustzentrum, Klinik und Poliklinik für Gynäkologie/ Klinische Studien
- Principal Investigator Name
- Volkmar Müller
- Principal Investigator Email
- v.mueller@uke.de
- Contact Person Name
- Volkmar Müller
- Contact Person Email
- v.mueller@uke.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Tjoung-Won Park-Simon
- Principal Investigator Email
- Park-Simon.Tjoung-Won@mh-hannover.de
- Contact Person Name
- Tjoung-Won Park-Simon
- Contact Person Email
- Park-Simon.Tjoung-Won@mh-hannover.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Interdisziplinäres Brustzentrum
- Principal Investigator Name
- Sherko Kümmel
- Principal Investigator Email
- s.kuemmel@kem-med.com
- Contact Person Name
- Sherko Kümmel
- Contact Person Email
- s.kuemmel@kem-med.com
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- Gynäkologische Onkologie
- Principal Investigator Name
- Carlo Fremd
- Principal Investigator Email
- Carlo.Fremd@med.uni-heidelberg.de
- Contact Person Name
- Carlo Fremd
- Contact Person Email
- Carlo.Fremd@med.uni-heidelberg.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Pauline Wimberger
- Principal Investigator Email
- pauline.wimberger@ukdd.de
- Contact Person Name
- Pauline Wimberger
- Contact Person Email
- pauline.wimberger@ukdd.de
Italy
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 19
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Onco-Ematology, SC ONCOLOGY
- Principal Investigator Name
- Alberto Zambelli
- Principal Investigator Email
- azambelli@asst-pg23.it
- Contact Person Name
- Alberto Zambelli
- Contact Person Email
- azambelli@asst-pg23.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Antonino Musolino
- Principal Investigator Email
- antonino.musolino@irst.emr.it
- Contact Person Name
- Antonino Musolino
- Contact Person Email
- antonino.musolino@irst.emr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Medical Oncology and Haematology
- Principal Investigator Name
- Claudio Zamagni
- Principal Investigator Email
- claudio.zamagni@aosp.bo.it
- Contact Person Name
- Claudio Zamagni
- Contact Person Email
- claudio.zamagni@aosp.bo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology Unit
- Principal Investigator Name
- Giampaolo Bianchini
- Principal Investigator Email
- bianchini.giampaolo@hsr.it
- Contact Person Name
- Giampaolo Bianchini
- Contact Person Email
- bianchini.giampaolo@hsr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. di Oncologia Medica - Breast unit
- Principal Investigator Name
- Rebecca Pedersini
- Principal Investigator Email
- rebecca.pedersini@gmail.com
- Contact Person Name
- Rebecca Pedersini
- Contact Person Email
- rebecca.pedersini@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 23
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Eva María Ciruelos Gil
- Principal Investigator Email
- eva.ciruelos@gmail.com
- Contact Person Name
- Eva María Ciruelos Gil
- Contact Person Email
- eva.ciruelos@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Isabel Echavarria Diaz-Guardamino
- Principal Investigator Email
- isabel.echavarria@salud.madrid.org
- Contact Person Name
- Isabel Echavarria Diaz-Guardamino
- Contact Person Email
- isabel.echavarria@salud.madrid.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rafael Villanueva Vazquez
- Principal Investigator Email
- ravillanueva@iconcologia.net
- Contact Person Name
- Rafael Villanueva Vazquez
- Contact Person Email
- ravillanueva@iconcologia.net
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Begoña Bermejo de las Heras
- Principal Investigator Email
- begobermejo@gmail.com
- Contact Person Name
- Begoña Bermejo de las Heras
- Contact Person Email
- begobermejo@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Meritxell Bellet Ezquerra
- Principal Investigator Email
- mbellet@vhio.net
- Contact Person Name
- Meritxell Bellet Ezquerra
- Contact Person Email
- mbellet@vhio.net
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Medical Oncology
- Principal Investigator Name
- Javier Cortes Castan
- Principal Investigator Email
- javier.cortes@maj3.health
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- javier.cortes@maj3.health
- Site Name
- Hospital Beata Maria Ana (duplicate entry name in record)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Javier Cortes Castan
- Principal Investigator Email
- javier.cortes@maj3.health
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- javier.cortes@maj3.health
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Site management
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Other Third Party Duty
- Name
- Bioclinica Inc.
- Responsibilities
- Other Third Party Duty
- Name
- 4g Clinical LLC
- Responsibilities
- 3
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Other Third Party Duty","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Site management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- RO7840734
- Active Substance
- RGT-419B
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- RO7197597
- Active Substance
- GIREDESTRANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- ABEMACICLIB
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Combination Treatment
- Yes
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