Clinical trial NCT06428409: A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

* About the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
* How many people have the cancer respond (get smaller or go away) to treatment


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has one of the following cancers:

  * Unresectable or metastatic colorectal cancer
  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
  * Advanced and/or unresectable biliary tract cancer (BTC)
* Has received prior therapy for the cancer
* Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of severe eye disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Primary outcomes:
measure: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
timeFrame: Up to approximately 4 weeks
measure: Number of Participants Who Experience One or More Adverse Events (AEs):
timeFrame: Up to approximately 53 months
measure: Number of Participants who Discontinue Study Treatment due to an AE
timeFrame: Up to approximately 53 months
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 53 months
Secondary outcomes:
measure: Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 53 months
measure: Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 53 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 53 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA ( Site 0317)
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus ( Site 0299)
state: Colorado
city: Denver
country: United States
facility: UCHealth Cherry Creek Medical Center ( Site 0326)
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Highlands Ranch Hospital ( Site 0325)
state: Colorado
city: Washington
country: United States
facility: Sibley Memorial Hospital ( Site 0310)
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida College of Medicine ( Site 0281)
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 0287)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
state: Georgia
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
state: New York
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center ( Site 0316)
state: Texas
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
state: Virginia
city: Madison
country: United States
facility: University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
state: Wisconsin
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0003)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
state: Queensland
city: East Melbourne
country: Australia
facility: Epworth Freemasons ( Site 0005)
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 0004)
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research ( Site 0002)
state: Western Australia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre ( Site 0027)
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0023)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 0048)
state: Araucania
city: Providencia
country: Chile
facility: FALP-UIDO ( Site 0041)
state: Region M. De Santiago
city: Santiago.
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0047)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo ( Site 0043)
state: Region M. De Santiago
city: Beijing
country: China
facility: Beijing Cancer hospital-Digestive Oncology ( Site 0061)
state: Beijing
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
state: Fujian
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center. ( Site 0064)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital-intervention department ( Site 0066)
state: Hunan
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University ( Site 0068)
state: Sichuan
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
state: Lombardia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0121)
state: Chiba
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0122)
state: Kanagawa
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0161)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 0164)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0163)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0162)
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
state: Asturias
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
state: Geneve
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli ( Site 0201)
state: Ticino
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0223)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 0225)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0221)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
city: London
country: United Kingdom
facility: Barts Health NHS Trust ( Site 0263)
state: England
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 0262)
state: England
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire ( Site 0266)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: