Clinical trial • Phase I/II • Oncology
SKB410 for Advanced/metastatic solid tumor
Phase I/II trial of SKB410 for Advanced/metastatic solid tumor. open-label, none/not specified-controlled. 213 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced/metastatic solid tumor
- Trial Stage
- Phase I/II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 10-12-2024
- First CTIS Authorization Date
- 20-05-2025
Trial design
open-label, none/not specified-controlled Phase I/II trial across 12 sites in Spain, Netherlands, France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 213
- Trial Duration For Participant
- 981
Eligibility
Recruits 213 No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent process not specified in the record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent process not specified in the record.
Inclusion criteria
- {"criterion_text":"-Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments"}
- {"criterion_text":"-If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)"}
- {"criterion_text":"-If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load"}
- {"criterion_text":"-If hepatitis C virus (HCV) infected, must have undetectable HCV viral load"}
Exclusion criteria
- {"criterion_text":"-Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease"}
- {"criterion_text":"-Has uncontrolled significant cardiovascular disease or cerebrovascular disease"}
- {"criterion_text":"-Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing"}
- {"criterion_text":"-Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage"}
- {"criterion_text":"-Is HIV-positive and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
- {"criterion_text":"-Known additional malignancy that is progressing or has required active treatment within the past 2 years"}
- {"criterion_text":"-Known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
- {"criterion_text":"-Active infection requiring systemic therapy, with exceptions"}
- {"criterion_text":"-History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
- {"criterion_text":"-Has HBV or HCV infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"-Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"-Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"-Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"-Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by the investigator"}
- {"endpoint_text":"-Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC)","definition_or_measurement_approach":""}
- {"endpoint_text":"-AUC of MK-3120 Total Antibody (TAb)","definition_or_measurement_approach":""}
- {"endpoint_text":"-AUC of MK-3120 Free Payload","definition_or_measurement_approach":""}
- {"endpoint_text":"-Maximum Concentration (Cmax) of MK-3120 ADC","definition_or_measurement_approach":""}
- {"endpoint_text":"-Cmax of MK-3120 TAb","definition_or_measurement_approach":""}
- {"endpoint_text":"-Cmax of MK-3120 Free Payload","definition_or_measurement_approach":""}
- {"endpoint_text":"-Minimum concentration (Cmin) of MK-3120 ADC","definition_or_measurement_approach":""}
- {"endpoint_text":"-Cmin of MK-3120 Tab","definition_or_measurement_approach":""}
- {"endpoint_text":"-Cmin of MK-3120 Free Payload","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 213
- Recruitment Window Months
- 32
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms. ICF documents are present for Spain (Spanish), Netherlands (Dutch) and France (French) as per the publication documents list. No assent process or age-specific consent handling is specified in the record.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 68
Spain
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 351
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Iván Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Contact Person Name
- Marta Gil Martín
- Contact Person Email
- contactfortrialsICOLH@iconcologia.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Bernard Doger de Speville
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Contact Person Name
- Javier Garcia Corbacho
- Contact Person Email
- fasestempranas@ibima.eu
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 344
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Department of medical oncology
- Contact Person Name
- Mariette Labots
- Contact Person Email
- medonc-phase1@amsterdamumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Clinical Research Unit
- Contact Person Name
- Tim Schutte
- Contact Person Email
- fase1secretariaat@nki.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Carla Herpen, van
- Contact Person Email
- Studies.onco@radboudumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- interne.oncologie@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 348
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical oncology
- Contact Person Name
- Antoine Deleuze
- Contact Person Email
- a.deleuze@rennes.unicancer.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical oncology
- Contact Person Name
- Cécile Vicier
- Contact Person Email
- vicierc@ipc.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical oncology
- Contact Person Name
- Cyril Abdeddaim
- Contact Person Email
- c-abdeddaim@o-lambret.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical oncology
- Contact Person Name
- Yohann Loriot
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Signant Health Global Solutions Limited
- Responsibilities
- code 3
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code 4
Third parties
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-3120
- Active Substance
- SKB410
- Modality
- ADC
- Routes Of Administration
- SOLUTION FOR INJECTION/INFUSION
- Combination Treatment
- Yes
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