Clinical trial • Phase I/II • Oncology
UBAMATAMAB for Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Primary peritoneal cancer
Phase I/II trial of UBAMATAMAB for Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Primary peritoneal cancer. Randomised, adaptive.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Ovarian cancer | Endometrial cancer | Fallopian tube cancer | Primary peritoneal cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-05-2024
- First CTIS Authorization Date
- 25-06-2024
Trial design
Randomised, adaptive Phase I/II trial in Netherlands, Belgium, France and others.
- Randomised
- Yes
- Adaptive
- Yes
- Biomarker Stratified
- True, MUC16 tumor expression (MUC16 positivity ≥25% by IHC used for endometrial cohorts)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 452
Eligibility
Recruits 452 No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrolls adult patients only (public title and population indicate adult patients). Informed consent is obtained from adult participants; assent is not applicable..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrolls adult patients only (public title and population indicate adult patients). Informed consent is obtained from adult participants; assent is not applicable.
Inclusion criteria
- {"criterion_text":"- Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following: a. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening), not required for low-grade serous carcinoma); b. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts); documented relapse or progression on or after the most recent line of therapy; no standard therapy options likely to convey clinical benefit\n- Adequate organ and bone marrow function as defined in the protocol\n- Life expectancy of at least 3 months\n- Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.\n- Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy: a. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol; b. 1-4 prior lines of systemic therapy, as described in the protocol\n- Other protocol-defined inclusion criteria apply"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol\n- Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)\n- Prior treatment with a MUC16 - targeted therapy\n- Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol\n- History and/or current cardiac findings as defined in the protocol\n- Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen\n- Other protocol-defined exclusion criteria apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- In the Dose Escalation Phase: Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of participants experiencing dose-limiting toxicity (DLT) during the Dose Escalation Phase for ubamatamab monotherapy and in combination with cemiplimab"}
- {"endpoint_text":"- In the Dose Escalation Phase: Number of participants with Treatment-emergent adverse event (TEAE)s (including immune (imAEs)) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of participants with treatment-emergent adverse events (including immune-related AEs) during Dose Escalation Phase for ubamatamab monotherapy and in combination with cemiplimab"}
- {"endpoint_text":"- In the Dose Escalation Phase: Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of participants experiencing serious adverse events during Dose Escalation Phase for ubamatamab monotherapy and in combination with cemiplimab"}
- {"endpoint_text":"- In the Dose Escalation Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Number of deaths observed during Dose Escalation Phase for ubamatamab monotherapy and in combination with cemiplimab"}
- {"endpoint_text":"- In the Dose Escalation Phase: Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of participants with laboratory abnormalities grade ≥3 per CTCAE during Dose Escalation Phase"}
- {"endpoint_text":"- In the Dose Escalation Phase: Concentration of REGN4018 in serum over time for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of REGN4018 (ubamatamab) over time"}
- {"endpoint_text":"- In the Dose Expansion Phase: Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"ORR as defined by RECIST 1.1 in Dose Expansion Phase for ubamatamab monotherapy and in combination with cemiplimab"}
Secondary endpoints
- {"endpoint_text":"- In the Dose Escalation Phase: ORR based on RECIST 1.1 for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Objective response rate (RECIST 1.1) during Dose Escalation Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of treatment-emergent adverse events (including immune AEs) in Dose Expansion Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Number of participants with SAEs for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of serious adverse events in Dose Expansion Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Number of deaths in Dose Expansion Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Count of grade ≥3 laboratory abnormalities per CTCAE in Dose Expansion Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Concentration of ubamatamab in serum over time for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of ubamatamab over time in Dose Expansion Phase"}
- {"endpoint_text":"- In the Dose Expansion Phase: Change from baseline in QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score"}
- {"endpoint_text":"- In the Dose Expansion Phase: Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning score"}
- {"endpoint_text":"- In the Dose Expansion Phase: Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score (Not applicable to Endometrial Cancer Cohort) for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Change from baseline in MOST-Abdominal index score (ovarian symptom measure); not applicable to Endometrial Cancer cohort"}
- {"endpoint_text":"- In the Dose Expansion Phase: Time to deterioration in GHS/QoL, physical functioning, and abdominal symptoms for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Time-to-event analysis for deterioration in GHS/QoL, physical functioning, and abdominal symptoms"}
- {"endpoint_text":"- In the Dose Expansion Phase: Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Change from baseline in EQ-5D quality of life measure"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: ORR based on iRECIST for ubamatamab monotherapy and with cemiplimab","definition_or_measurement_approach":"Objective response rate per iRECIST across Dose Escalation and Expansion Phases"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Best overall response (BOR) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Best overall response assessed by RECIST 1.1 and iRECIST"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Duration of response (DOR) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Duration of response per RECIST 1.1 and iRECIST"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Disease control rate based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Disease control rate per RECIST 1.1 and iRECIST"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Progression-free survival (PFS) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Progression-free survival per RECIST 1.1 and iRECIST"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Complete Response (CR) rate for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"Complete response rate as assessed by RECIST/iRECIST"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Cancer antigen-125 (CA-125) response for ubamatamab monotherapy and in combination with cemiplimab","definition_or_measurement_approach":"CA-125 biomarker response measured per protocol"}
- {"endpoint_text":"- In the Dose Escalation and Dose Expansion Phase: Presence or absence of anti-drug antibodies against ubamatamab and cemiplimab","definition_or_measurement_approach":"Assessment of immunogenicity: presence/absence of anti-drug antibodies against ubamatamab and cemiplimab"}
Recruitment
- Planned Sample Size
- 452
- Recruitment Window Months
- 97
- Consent Approach
- Informed consent obtained from adult participants. Subject information sheets and informed consent forms (L1_SIS and ICF) are provided in multiple languages (English, Dutch/NL, French/FR/BE, Italian, Spanish and country variants) and separate ICFs are present for genomics and pregnancy/birth substudies (separate genomics and pregnancy ICF documents listed).
Methods
- K1_Recruitment Procedure / K1_Recruitment arrangements documents present (country-specific recruitment arrangements documents listed for NL, BE, IT, ES)
- K2 recruitment materials including GP letter / Dear Dr Letter (indicates outreach to referring physicians/GPs)
- Site-based recruitment at listed hospital/clinic trial sites (site contact details provided in country Part II records)
- Recruitment materials / subject ID card (document titles present)
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 237
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Principal Investigator Name
- Anna Reyners
- Principal Investigator Email
- a.k.l.reyners@umcg.nl
- Contact Person Name
- Anna Reyners
- Contact Person Email
- a.k.l.reyners@umcg.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal Oncology
- Principal Investigator Name
- Ingrid Boere
- Principal Investigator Email
- i.boere@erasmusmc.nl
- Contact Person Name
- Ingrid Boere
- Contact Person Email
- i.boere@erasmusmc.nl
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Medical Oncology
- Principal Investigator Name
- Vicky Soomers
- Principal Investigator Email
- vicky.soomers@radboudumc.nl
- Contact Person Name
- Vicky Soomers
- Contact Person Email
- vicky.soomers@radboudumc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 25-06-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 66
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology and Haematology
- Principal Investigator Name
- David Schroder
- Principal Investigator Email
- David.SCHRODER@ghdc.be
- Contact Person Name
- David Schroder
- Contact Person Email
- David.SCHRODER@ghdc.be
- Site Name
- UZ Leuven
- Department Name
- Gynaecological Oncology
- Principal Investigator Name
- Els Van Nieuwenhuysen
- Principal Investigator Email
- els.vannieuwenhuysen@uzleuven.be
- Contact Person Name
- Els Van Nieuwenhuysen
- Contact Person Email
- els.vannieuwenhuysen@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Konstantinos Papadimitriou
- Principal Investigator Email
- Konstantinos.papadimitriou@uza.be
- Contact Person Name
- Konstantinos Papadimitriou
- Contact Person Email
- Konstantinos.papadimitriou@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 09-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 7
- Number Of Participants
- 51
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Judith Michels
- Principal Investigator Email
- judith.michels@gustaveroussy.fr
- Contact Person Name
- Judith Michels
- Contact Person Email
- judith.michels@gustaveroussy.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benoit You
- Principal Investigator Email
- benoit.you@chu-lyon.fr
- Contact Person Name
- Benoit You
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Provence Alpes Cote dAzur
- Principal Investigator Name
- Follana Philippe
- Principal Investigator Email
- philippe.follana@nice.unicancer.fr
- Contact Person Name
- Follana Philippe
- Contact Person Email
- philippe.follana@nice.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francois Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- Francois Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical oncology
- Principal Investigator Name
- Isabelle RAY-COQUARD
- Principal Investigator Email
- Isabelle.ray-coquard@lyon.unicancer.fr
- Contact Person Name
- Isabelle RAY-COQUARD
- Contact Person Email
- Isabelle.ray-coquard@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Coriolan Lebreton-Bourigault
- Principal Investigator Email
- c.lebreton@bordeaux.unicancer.fr
- Contact Person Name
- Coriolan Lebreton-Bourigault
- Contact Person Email
- c.lebreton@bordeaux.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology
- Principal Investigator Name
- Florence Joly
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence Joly
- Contact Person Email
- f.joly@baclesse.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 09-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Gynecology Oncology Department
- Principal Investigator Name
- Nicoletta Colombo
- Principal Investigator Email
- Nicoletta.colombo@ieo.it
- Contact Person Name
- Nicoletta Colombo
- Contact Person Email
- Nicoletta.colombo@ieo.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Domenica Lorusso
- Principal Investigator Email
- Domenica.lorusso@hunimed.eu
- Contact Person Name
- Domenica Lorusso
- Contact Person Email
- Domenica.lorusso@hunimed.eu
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Gynecological oncology
- Principal Investigator Name
- Sabrina Cecere
- Principal Investigator Email
- s.cecere@istitutotumori.na.it
- Contact Person Name
- Sabrina Cecere
- Contact Person Email
- s.cecere@istitutotumori.na.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Gynecological Oncology
- Principal Investigator Name
- Vanda Salutari
- Principal Investigator Email
- Vanda.salutari@policlinicogemelli.it
- Contact Person Name
- Vanda Salutari
- Contact Person Email
- Vanda.salutari@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 06-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 8
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno Garcia
- Principal Investigator Email
- Victor.Moreno@startmadrid.com
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- Victor.Moreno@startmadrid.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Medical oncology
- Principal Investigator Name
- Alexandra Cortegoso
- Principal Investigator Email
- alexandra.sabela.cortegoso.mosquera@sergas.es
- Contact Person Name
- Alexandra Cortegoso
- Contact Person Email
- alexandra.sabela.cortegoso.mosquera@sergas.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Casado Herraez
- Principal Investigator Email
- antoniocasado6@gmail.com
- Contact Person Name
- Antonio Casado Herraez
- Contact Person Email
- antoniocasado6@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Gynecological Oncology
- Principal Investigator Name
- Carmen García Durán
- Principal Investigator Email
- cgarciaduran@vhio.net
- Contact Person Name
- Carmen García Durán
- Contact Person Email
- cgarciaduran@vhio.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Gonzalez Martin
- Principal Investigator Email
- agonzalezma@unav.es
- Contact Person Name
- Antonio Gonzalez Martin
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Ochoa de Olza Amat
- Principal Investigator Email
- maochoa@iconcologia.net
- Contact Person Name
- Maria Ochoa de Olza Amat
- Contact Person Email
- maochoa@iconcologia.net
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Oncology
- Principal Investigator Name
- Pilar Barretina
- Principal Investigator Email
- mpbarretina@iconcologia.net
- Contact Person Name
- Pilar Barretina
- Contact Person Email
- mpbarretina@iconcologia.net
- Site Name
- Complex additional Spanish site (listed)
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Contract Research Organization, Pharmacovigilance Services
- Name
- Icon Clinical Research Limited
- Responsibilities
- Central Laboratory
Third parties
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Contract Research Organization, Pharmacovigilance Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Interactive Voice Response System/ Interactive Web Response System","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"Master Laboratory Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"H&E Pathology review, PD-L1 and MUC16 analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Central management of Image Data","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Andersonbrecon Inc.","duties_or_roles":"Investigational Product Distribution to Sites, Return and Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ubamatamab
- Active Substance
- UBAMATAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation listed (investigational)
- Investigational Product Name
- Cemiplimab / LIBTAYO
- Active Substance
- CEMIPLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation present for LIBTAYO (EU/1/19/1376/001) for cemiplimab (marketed product LIBTAYO); IMP variant used in study
- Investigational Product Name
- Sarilumab / Kevzara
- Active Substance
- SARILUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion / Subcutaneous injection (marketing product Kevzara listed as subcutaneous)
- Route
- Intravenous infusion / Subcutaneous injection
- Authorisation Status
- Kevzara marketing authorisation listed (EU/1/17/1196/013) for sarilumab; IMP variants used
- Investigational Product Name
- Tocilizumab
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- No specific marketing authorisation number listed in product entry
- Combination Treatment
- Yes
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