The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease. This study is seeking for participants who either have cancer: * that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable), * has spread through the body (metastatic), or have some cancer left over after surgery. This study will have five parts. * Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants. * Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers. * Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab. * Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Given into the vein (IV; intravenously)
400 mg every 6 weeks, given by IV
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
Presbyterian/St Lukes Medical Center
Denver, Colorado, United States
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Through 30 days after last study treatment, up to approximately 5 years
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 28 days
Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level
Time frame: Through 30-37 days after last study treatment; up to approximately 5 years
Confirmed objective response rate (ORR) by investigator assessment
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.
Time frame: Up to approximately 5 years
Complete response rate (CRR)
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Time frame: Up to approximately 5 years
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Time frame: Up to approximately 5 years
Progression-free survival (PFS)
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Time frame: Up to approximately 5 years
Invasive disease-free survival (iDFS)
The time from the start of any study treatment until the date of first occurrence of one of the following events: ipsilateral invasive breast tumor (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant (metastatic) recurrence; contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous of basal cell skin cancer); or death from any cause.
Time frame: Up to approximately 5 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment, up to approximately 3 years
Incidence of antidrug antibodies (ADAs)
To be summarized using descriptive statistics.
Time frame: Through 30-37 days after last study treatment, up to approximately 3 years
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