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

Phase 1
Recruiting
Conditions
Gastrointestinal Cancer
Interventions
Registration Number
NCT06596694
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
130
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
  • 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)/pneumonitis that required steroids, or has current ILD/pneumonitis, and/or suspected ILD/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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Patritumab deruxtecanPatritumab deruxtecanParticipants 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.
Primary Outcome Measures
NameTimeMethod
Number of Participants with One or More Adverse Events (AEs)Up to approximately 45 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.

Number of Participants who Discontinue Study Intervention Due to an AEUp to approximately 45 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

Objective Response Rate (ORR)Up to approximately 45 months

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)Up to 21 days

DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.

Secondary Outcome Measures
NameTimeMethod
Duration of Response (DOR)Up to approximately 45 months

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

Progression Free Survival (PFS)Up to approximately 45 months

PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

Maximum Plasma Concentration (Cmax) of Patritumab DeruxtecanAt designated time points (up to ~45 months)

Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan.

Overall Survival (OS)Up to approximately 45 months

OS is the length of time from when the participant starts treatment until death from any cause.

Trough Concentration (Ctrough) of Patritumab DeruxtecanAt designated time points (up to ~45 months)

Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan.

Trial Locations

Locations (59)

UCLA Hematology Oncology Santa Monica ( Site 1205)

🇺🇸

Santa Monica, California, United States

Sibley Memorial Hospital ( Site 1208)

🇺🇸

Washington, District of Columbia, United States

University of Florida ( Site 1202)

🇺🇸

Gainesville, Florida, United States

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

🇺🇸

Miami Beach, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)

🇺🇸

Marietta, Georgia, United States

University of Chicago Medical Center ( Site 1204)

🇺🇸

Chicago, Illinois, United States

Renown Regional Medical Center ( Site 1221)

🇺🇸

Reno, Nevada, United States

NYU Langone Hospital - Long Island ( Site 1230)

🇺🇸

Mineola, New York, United States

Perlmutter NYU Cancer Center ( Site 1212)

🇺🇸

New York, New York, United States

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)

🇺🇸

Roanoke, Virginia, United States

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UCLA Hematology Oncology Santa Monica ( Site 1205)
🇺🇸Santa Monica, California, United States
Study Coordinator
Contact
888-577-8839

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