This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks. This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Given into the vein (IV, intravenous) every 2 weeks
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Gilbert, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Glendale, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Time frame: Approximately 3 years
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Time frame: Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with laboratories abnormalities
Time frame: Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEs
Time frame: Approximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
Time frame: Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Time frame: Approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
PFS is defined as the time from the start of study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first
Time frame: Approximately 5 years
Overall Survival (OS)
The time from the start of study treatment to the date of death due to any cause
Time frame: Approximately 5 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Analyzed through cycle 2.
Time frame: Approximately 1 month
PK parameter - Maximum concentration (Cmax)
Analyzed through end of treatment.
Time frame: Through 30-37 days after the last dose of DV; approximately 5 years
PK parameter - Trough concentration (Ctrough)
Analyzed through end of treatment.
Time frame: Through 30-37 days after the last dose of DV; approximately 5 years
Incidence of antidrug antibodies (ADAs)
Time frame: Through 30-37 days after the last dose of DV; approximately 5 years
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