Clinical trial • Phase I/II • Oncology
SKB410 for High-risk non-muscle invasive bladder cancer (NMIBC) | Carcinoma in situ (CIS)
Phase I/II trial of SKB410 for High-risk non-muscle invasive bladder cancer (NMIBC) | Carcinoma in situ (CIS). None/Not specified-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- High-risk non-muscle invasive bladder cancer (NMIBC) | Carcinoma in situ (CIS)
- Trial Stage
- Phase I/II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 03-09-2025
- First CTIS Authorization Date
- 22-12-2025
Trial design
None/Not specified-controlled, adaptive Phase I/II trial in Netherlands, Greece, Spain and others.
- Comparator
- None/Not specified
- Adaptive
- True, Dose-escalation design with DLT evaluation (phase I/II integrated); specific escalation rules not provided in the CTIS record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 46
Eligibility
Recruits 46 No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is via adult informed consent forms (site-specific L1_ICF_Main consent documents); no assent or paediatric consent described..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is via adult informed consent forms (site-specific L1_ICF_Main consent documents); no assent or paediatric consent described.
Inclusion criteria
- {"criterion_text":"- Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally."}
- {"criterion_text":"- Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1)."}
- {"criterion_text":"- Bacillus Calmette-Guérin (BCG)-, exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC >12 months but ≤24 months after the last BCG dose."}
- {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy."}
- {"criterion_text":"- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation."}
- {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening."}
Exclusion criteria
- {"criterion_text":"- Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC)."}
- {"criterion_text":"- Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years."}
- {"criterion_text":"- Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture."}
- {"criterion_text":"- Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours)."}
- {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention."}
- {"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":"- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease."}
- {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years."}
- {"criterion_text":"- Has known active central nervous system metastases and/or carcinomatous meningitis."}
- {"criterion_text":"- Has active infection requiring systemic therapy."}
- {"criterion_text":"- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD."}
- {"criterion_text":"- Has not adequately recovered from major surgery or has ongoing surgical complications."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Participants Who Experience a Dose-limiting Toxicity (DLT)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to AEs","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Complete Response Rate (CRR)","definition_or_measurement_approach":"CRR at 3 months based on local assessment"}
Recruitment
- Planned Sample Size
- 46
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent obtained from adult participants via site-specific L1_ICF_Main consent documents. Multiple language versions are available (examples in documents list: NLD_EN, GRC_EL, ESP_ES, ITA_IT, NOR_NN, AUT_DE, FRA_FR, BEL_FR/EN/NL). Optional consent forms for items such as pregnancy follow-up and pregnant partner are included. No paediatric assent procedures are described.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 32
Netherlands
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 30-12-2025
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Oncology
- Contact Person Name
- Kees Hendriksen
- Contact Person Email
- urologie@nki.nl
Greece
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 94
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- International Oncology Center - Oncology Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 14-11-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 56
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Urology Department
- Contact Person Name
- Bernardo Herrera Imbroda
- Contact Person Email
- ber.urologia@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urology Department
- Contact Person Name
- Félix Guerrero Ramos
- Contact Person Email
- felixguerrero@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro Ricerche Cliniche di Verona S.r.l.
- Contact Person Name
- Andrea ZIVI
- Contact Person Email
- andrea.zivi@aovr.veneto.it
Norway
- Earliest CTIS Part Ii Submission Date
- 24-11-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 44
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Akershus University Hospital
- Department Name
- Department of Urology, Surgical Division
- Contact Person Name
- Stig Müller
- Contact Person Email
- Stig.Muller@ahus.no
Austria
- Earliest CTIS Part Ii Submission Date
- 26-11-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Urologie
- Contact Person Name
- Kilian Gust
- Contact Person Email
- kilian.gust@meduniwien.ac.at
France
- Earliest CTIS Part Ii Submission Date
- 30-10-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 54
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d’Innovation Thérapeutique et des Essais Précoces
- Contact Person Name
- Yohann LORIOT
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-11-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 50
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oncology
- Contact Person Name
- Camille Berquin
- Contact Person Email
- camille.berquin@uzgent.be
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
- PPD Global Central Labs
- Responsibilities
- sponsorDuties code 4
- Name
- Signant Health Global Solutions Limited
- Responsibilities
- sponsorDuties code 3
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":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-3120
- Active Substance
- SKB410
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravesical
- Route
- Intravesical
- Authorisation Status
- prodAuthStatus: 1
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)