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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Gastrointestinal Cancer

Treatments: Biological: Patritumab deruxtecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06596694

2024-512442-41-00 (Registry Identifier)

1022-011

MK-1022-011 (Other Identifier)

U1111-1305-0677 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Patritumab deruxtecan

Experimental group

Description:

Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.

Treatment:

Biological: Patritumab deruxtecan