Gastrointestinal Cancer
Conditions
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
Interventions
BIOLOGICALPatritumab deruxtecan
Administered via intravenous (IV) infusion
Sponsors
Merck Sharp & Dohme LLC
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants with One or More Adverse Events (AEs) | Up to approximately 44 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 AE | Up to approximately 44 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 44 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Up to approximately 44 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 44 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. |
| Overall Survival (OS) | Up to approximately 44 months | OS is the length of time from when the participant starts treatment until death from any cause. |
| Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan | At designated time points (up to ~44 months) | Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan. |
| Trough Concentration (Ctrough) of Patritumab Deruxtecan | At designated time points (up to ~44 months) | Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan. |
Countries
Australia, Canada, Chile, China, France, Israel, Italy, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed