A Study of Emi-Le in Participants with Solid Tumors
This first-in-human (FIH) study will test the safety, side effects, and antitumor activity of a drug called Emi-Le ((Emiltatug Ledadotin, formerly XMT-1660). A side effect is anything a drug does to the body besides treating the disease. Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started (advanced) or spread through the body (metastatic). The study will have three parts. The first part called Dose Escalation, will find out how much Emi-Le should be given to participants. The second part called Dose Expansion, will use the dose found in the first part to find out how safe Emi-Le is and if it works to treat solid tumors. The third part, the Phase 2 part of the trial, called EMBLEM-1, will find out if Emi-Le works to treat aggressive Adenoid Cystic Carcinoma and continue to check how safe Emi-Le is.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Emi-Le will be administered through a vein in your arm or port catheter (intravenously)
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation)
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le
Time frame: 17 months
Incidence of adverse events (Dose Escalation and Dose Expansion)
Assess the safety and tolerability of Emi-Le by determining the number of patients with adverse events from date of first dose to 60 days post last dose
Time frame: 3 years
Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: approximately 3 years
Objective Response Rate (ORR) (Dose Escalation)
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to approximately 3 years
Duration of response (DOR) (Dose Escalation, Dose Expansion, and EMBLEM-1)
The time from when response criteria are first met until disease progression or death in participants who achieve a complete or partial response
Time frame: Up to approximately 3 years
Maximum observed plasma concentration of Emi-Le and payload (Cmax) (Dose Escalation and Dose Expansion)
Cmax is the maximum concentration determined from the measured concentrations in plasma
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Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
RECRUITINGUC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGUCLA David Geffen School of Medicine, Division of Hematology/Oncology
Santa Monica, California, United States
RECRUITINGMayo Clinic - Jacksonville
Jacksonville, Florida, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITING...and 16 more locations
Time frame: Up to approximately 3 years
Area under the concentration-time curve of Emi-Le and payload (AUC) (Dose Escalation and Dose Expansion)
Area under the concentration-time curve for the last measurable concentration (AUC0-last) will be assessed as data permit
Time frame: Up to approximately 3 years
Antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) (Dose Escalation, Dose Expansion, and EMBLEM-1)
Assess the development of ADAs and NAbs to Emi-Le
Time frame: Up to approximately 3 years
Assess the overall survival (OS) of patients treated with Emi-Le (Dose Escalation, Dose Expansion, and EMBLEM-1)
The time from the date of first dose of study treatment to the date of death due to any cause
Time frame: Up to approximately 3 years
Incidence of adverse events (EMBLEM-1)
Assess the safety and tolerability of Emi-Le by determining the number of patients with adverse events from date of first dose to 60 days post last dose
Time frame: 3 years
Progression-free survival (PFS) (EMBLEM-1)
The time from the date of first dose of study treatment until the first date at which disease progression is objectively documented or date of death due to any cause, whichever occurs first
Time frame: Up to approximately 3 years