Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

Official title

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Overview

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Interventions

• Biological Patritumab deruxtecan
  Administered via intravenous (IV) infusion

Primary outcome measures

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) [Time frame: Up to 21 days]
• Number of Participants with One or More Adverse Events (AEs) [Time frame: Up to approximately 44 months]
• Number of Participants who Discontinue Study Intervention Due to an AE [Time frame: Up to approximately 44 months]
• Objective Response Rate (ORR) [Time frame: Up to approximately 44 months]

Secondary outcome measures (5)

• Duration of Response (DOR) [Time frame: Up to approximately 44 months]
• Progression Free Survival (PFS) [Time frame: Up to approximately 44 months]
• Overall Survival (OS) [Time frame: Up to approximately 44 months]
• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan [Time frame: At designated time points (up to ~44 months)]
• Trough Concentration (Ctrough) of Patritumab Deruxtecan [Time frame: At designated time points (up to ~44 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.
• Advanced and/or unresectable biliary tract cancer (BTC)
• Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
• Locally advanced unresectable or metastatic gastroesophageal cancer
• 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:

• Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
• Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
• Has evidence of any leptomeningeal disease
• Has clinically significant corneal disease
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 13 centers

• UCLA Hematology Oncology Santa Monica ( Site 1205) — Santa Monica
• University of Colorado Cancer Center ( Site 1200) — Aurora
• Sibley Memorial Hospital ( Site 1208) — Washington D.C.
• University of Florida ( Site 1202) — Gainesville
• Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) — Miami Beach
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 12 — Marietta
• University of Chicago Medical Center ( Site 1204) — Chicago
• Renown Regional Medical Center ( Site 1221) — Reno
• … and 5 more centers

China · 9 centers

• The First Affiliated Hospital of Anhui Medical University ( Site 0405) — Hefei
• Fujian Provincial Cancer Hospital ( Site 0408) — Fuzhou
• Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412) — Xiamen
• Southern Medical University Nanfang Hospital ( Site 0413) — Fuzhou
• The First Affiliated Hospital, Sun Yat-sen University ( Site 0404) — Guangzhou
• Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411) — Nanning
• Henan Cancer Hospital ( Site 0403) — Zhengzhou
• Zhongshan Hospital,Fudan University ( Site 0400) — Shanghai
• … and 1 more center

Australia · 4 centers

• Westmead Hospital ( Site 0100) — Sydney
• Alfred Health ( Site 0102) — Melbourne
• Austin Health ( Site 0103) — Melbourne
• One Clinical Research ( Site 0104) — Mount Pleasant

Chile · 4 centers

• Fundacion Arturo Lopez Perez ( Site 0301) — Santiago
• Centro de Oncología de Precisión ( Site 0305) — Santiago
• Clínica UC San Carlos de Apoquindo ( Site 0302) — Santiago
• Bradfordhill ( Site 0300) — Santiago

South Korea · 4 centers

• Seoul National University Hospital ( Site 0900) — Seodaemun-gu
• Severance Hospital, Yonsei University Health System ( Site 0903) — Seoul
• Asan Medical Center ( Site 0902) — Seoul
• Samsung Medical Center ( Site 0901) — Seoul

Spain · 4 centers

• Hospital Central de Asturias ( Site 1001) — Oviedo
• Hospital Universitari Vall d'Hebron ( Site 1000) — Barcelona
• Hospital Universitario Gregorio Maranon ( Site 1002) — Madrid
• Hospital Clinico San Carlos... ( Site 1003) — Madrid

Turkey (Türkiye) · 4 centers

• Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400) — Yenimahalle
• Dokuz Eylul Universitesi Hastanesi ( Site 1402) — Balçova
• Adana City Hospital ( Site 1404) — Adana
• Hacettepe Universite Hastaneleri ( Site 1401) — Ankara

Canada · 3 centers

• QEII Health Sciences Centre - Victoria General Site ( Site 0200) — Halifax
• Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206) — Toronto
• McGill University Health Centre ( Site 0202) — Montreal

France · 3 centers

• Hopital de la Croix Rousse ( Site 0502) — Lyon
• Hopital Beaujon ( Site 0500) — Clichy
• Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501) — Rennes

Israel · 3 centers

• Rambam Health Care Campus ( Site 0603) — Haifa
• Hadassah Medical Center ( Site 0602) — Jerusalem
• Sourasky Medical Center ( Site 0601) — Tel Aviv

Italy · 3 centers

• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700) — Milan
• ASST Grande Ospedale Metropolitano Niguarda ( Site 0701) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702) — Roma

Taiwan · 3 centers

• National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502) — Tainan
• National Taiwan University Hospital ( Site 1500) — Taipei
• Taipei Veterans General Hospital ( Site 1501) — Taipei

Switzerland · 2 centers

• Hopitaux Universitaires de Geneve HUG. ( Site 1102) — Geneva
• Universitaetsspital Zuerich ( Site 1105) — Zurich

Thailand · 2 centers

• Faculty of Medicine Siriraj Hospital ( Site 1301) — Bangkoknoi
• Ramathibodi Hospital ( Site 1302) — Ratchathewi

New Zealand · 1 center

• Harbour Cancer & Wellness ( Site 0800) — Auckland

Identifiers

NCT: NCT06596694 · 1022-011 · MK-1022-011 · 2024-512442-41-00 · U1111-1305-0677

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗