A Clinical Study of MK-2870 Alone or With Other Treatments 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

Overview

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments 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 of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

Interventions

• Biological Sacituzumab tirumotecan
  Given by IV infusion.
• Drug Fluorouracil (5-FU)
  5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
• Drug Leucovorin (LV) or levoleucovorin
  LV or levoleucovorin is administered by IV infusion every 2 weeks.
• Drug Rescue medication
  Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[H1\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
• Drug Supportive care measures
  Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
• Drug Cisplatin
  Given by IV infusion.
• Biological Pembrolizumab
  Given by IV infusion.

Primary outcome measures

• Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [Time frame: Up to approximately 4 weeks]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to approximately 63 months]
• Number of Participants who Discontinue Study Treatment due to an AE [Time frame: Up to approximately 63 months]
• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 63 months]

Secondary outcome measures (3)

• Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR [Time frame: Up to approximately 63 months]
• Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR [Time frame: Up to approximately 63 months]
• Overall Survival (OS) [Time frame: Up to approximately 63 months]

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 and has received prior therapy for the cancer
• Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
• Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
• Advanced and/or unresectable BTC and has not received prior therapy for the cancer
• For participants who have received prior therapy for 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
• For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
• History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 13 centers

• UCLA ( Site 0317) — Los Angeles
• University of Colorado Anschutz Medical Campus ( Site 0299) — Aurora
• University of Colorado Anschutz Medical Campus ( Site 0325) — Aurora
• University of Colorado Anschutz Medical Campus ( Site 0326) — Aurora
• Sibley Memorial Hospital ( Site 0310) — Washington D.C.
• University of Florida College of Medicine ( Site 0281) — Gainesville
• Mount Sinai Cancer Center ( Site 0287) — Miami Beach
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303) — Marietta
• … and 5 more centers

China · 6 centers

• Beijing Cancer hospital-Digestive Oncology ( Site 0061) — Beijing
• The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation — Fuzhou
• Wuhan Union Hospital Cancer Center. ( Site 0064) — Wuhan
• Hunan Cancer Hospital-intervention department ( Site 0066) — Changsha
• Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site — Shanghai
• West China Hospital, Sichuan University ( Site 0068) — Chengdu

Australia · 5 centers

• Westmead Hospital ( Site 0003) — Westmead
• Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Ser — Brisbane
• Epworth Freemasons ( Site 0005) — East Melbourne
• Frankston Hospital-Oncology and Haematology ( Site 0004) — Frankston
• One Clinical Research ( Site 0002) — Nedlands

Taiwan · 5 centers

• China Medical University Hospital ( Site 0223) — Taichung
• National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224) — Tainan
• National Taiwan University Hospital-Oncology ( Site 0225) — Taipei
• Taipei Veterans General Hospital ( Site 0221) — Taipei
• Chang Gung Medical Foundation-Linkou Branch ( Site 0222) — Taoyuan

Chile · 4 centers

• James Lind Centro de Investigacion del Cancer ( Site 0048) — Temuco
• FALP-UIDO ( Site 0041) — Providencia
• Clínica UC San Carlos de Apoquindo ( Site 0043) — Santiago
• Bradfordhill-Clinical Area ( Site 0047) — Santiago

South Korea · 4 centers

• Seoul National University Hospital ( Site 0161) — Seoul
• Severance Hospital, Yonsei University Health System ( Site 0164) — Seoul
• Asan Medical Center ( Site 0163) — Seoul
• Samsung Medical Center ( Site 0162) — Seoul

Canada · 3 centers

• The Ottawa Hospital Cancer Centre ( Site 0027) — Ottawa
• Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022) — Montreal
• McGill University Health Centre ( Site 0023) — Montreal

Italy · 3 centers

• Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Si — Milan
• ASST Grande Ospedale Metropolitano Niguarda ( Site 0102) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103) — Roma

Spain · 3 centers

• HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183) — Madrid
• Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182) — Oviedo
• Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181) — Barcelona

United Kingdom · 3 centers

• Barts Health NHS Trust ( Site 0263) — London
• Royal Free Hospital ( Site 0262) — London
• University Hospital Coventry & Warwickshire ( Site 0266) — Coventry

Japan · 2 centers

• National Cancer Center Hospital East ( Site 0121) — Kashiwa
• Kanagawa Cancer Center ( Site 0122) — Yokohama

Switzerland · 2 centers

• Hôpitaux Universitaires de Genève (HUG) ( Site 0202) — Geneva
• Ospedale Regionale Bellinzona e Valli ( Site 0201) — Bellinzona

Turkey (Türkiye) · 2 centers

• Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241) — Ankara
• Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242) — Ankara

Identifiers

NCT: NCT06428409 · 9999-02A · MK-9999-02A · 2023-508703-21-00 · U1111-1298-8273 · jRCT2031240178

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗