Clinical trial • Phase I/II • Oncology
sacituzumab tirumotecan for Colorectal cancer | Pancreatic ductal adenocarcinoma | Biliary tract cancer
Phase I/II trial of sacituzumab tirumotecan for Colorectal cancer | Pancreatic ductal adenocarcinoma | Biliary tract cancer. 119 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer | Pancreatic ductal adenocarcinoma | Biliary tract cancer
- Trial Stage
- Phase I/II
- Drug Modality
- ADC | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 20-03-2024
- First CTIS Authorization Date
- 08-07-2024
Trial design
Phase I/II trial across 6 sites in Spain, Italy.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 119
Eligibility
Recruits 119 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Assent/consent handling for vulnerable groups not described in the record..
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected=false). Assent/consent handling for vulnerable groups not described in the record.
Inclusion criteria
- {"criterion_text":"- 1.\tHas one of the following cancers: •\tUnresectable or metastatic colorectal cancer and has received prior therapy for the cancer •\tAdvanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer •\tAdvanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer •\tAdvanced and/or unresectable BTC and has not received prior therapy for the cancer"}
- {"criterion_text":"- 2.\tFor participants who have received prior therapy for cancer: \tHas recovered from any side effects due to previous cancer treatment"}
Exclusion criteria
- {"criterion_text":"- 1.\tHistory of severe eye disease"}
- {"criterion_text":"- 2.\tFor participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention."}
- {"criterion_text":"- 3.\tHistory of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1.\tNumber of Participants Who Experience a Dose-limiting Toxicity (DLT)","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2.\tNumber of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- 3.\tNumber of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
- {"endpoint_text":"- 4.\tObjective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
Secondary endpoints
- {"endpoint_text":"- 1.\tDuration of Response (DOR) per RECIST 1.1 as Assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
- {"endpoint_text":"- 2.\tProgression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
- {"endpoint_text":"- 3.\tOverall Survival (OS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 119
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent obtained from participants. Subject information and informed consent form documents are listed for Italy and Spain (languages include Italian and Spanish). Assent or specific consent procedures for minors or other vulnerable groups are not mentioned.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 20
Spain
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 630
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Jorge Hernando Cubero
- Contact Person Email
- jhernando@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Contact Person Name
- Andrés Muñoz Martín
- Contact Person Email
- andresjesus.munoz@salud.madrid.org
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Medical Oncology
- Contact Person Name
- Paula Jiménez Fonseca
- Contact Person Email
- palucaji@hotmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 20-05-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 658
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Oncologia Falck, Dipartimento di Ematologia e Oncologia
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- Salvatore.Siena@OspedaleNiguarda.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica I
- Contact Person Name
- Filippo Pietrantonio
- Contact Person Email
- Filippo.Pietrantonio@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Contact Person Name
- Giampaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Pra International
- Responsibilities
- central imaging
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- code 3
- Name
- Icon Clinical Research Limited
- Responsibilities
- code 4
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
Third parties
- {"country":"United States","full_name":"Pra International","duties_or_roles":"central imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche","duties_or_roles":"code 4","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- MK-2870
- Active Substance
- sacituzumab tirumotecan
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Investigational (MIA: IMP11011/00003)
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion.
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorized (EU/1/15/1024/002)
- Investigational Product Name
- CISPLATIN
- Active Substance
- cisplatin
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- fluorouracil
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Investigational Product Name
- CALCIUM FOLINATE / CALCIUM LEVOFOLINATE
- Active Substance
- calcium folinate
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Combination Treatment
- Yes
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