A Study of SGN-MesoC2 in Advanced Solid Tumors
NCT Number: NCT06466187
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung|Ovarian Neoplasms|Pancreatic Adenocarcinoma|Colorectal Neoplasms|Mesothelioma|Other Solid Tumors
Interventions: DRUG: SGN-MesoC2
Sponsor: Seagen Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 365
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2028-11-01
Locations: South Texas Accelerated Research Therapeutics, San Antonio, Texas, 78229, United States|START Mountain Region, West Valley City, Utah, 84119, United States

Summary:
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.

Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs.

This clinical trial uses an experimental drug called SGN-MesoC2. SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.

This study will have 3 parts. Part A and Part B of the study will find out how much SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if SGN-MesoC2 is safe and if it works to treat solid tumor cancers.

Primary Outcome Measures: Number of participants with adverse events (AEs), An AE is 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., Through 30-37 days after the last dose of study treatment, 48 Months|Number of participants with laboratory abnormalities, Through 30-37 days after the last dose of study treatment, 48 Months|Number of participants with dose modifications, Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs, Up to 4 months|Number of participants with dose-limiting toxicities (DLTs), Incidence of dose-limiting toxicities (DLTs), Cycle 1 (21 days)
Secondary Outcome Measures: Objective response rate (ORR), ORR is defined as the proportion of participants in the relevant analysis set with best response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1., Approximately 1 year 4 months|Best response, The best timepoint response achieved for the subject during the protocol specified period according to RECIST V1.1., Approximately 1 year 4 months|Duration of response (DOR), DOR is defined as the time interval from first occurrence of documented objective response to the time of progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first., Approximately 1 year 4 months|Disease control rate (DCR), DCR is defined as the proportion of participants with best response of CR, PR or stable disease (SD) according to RECIST v1.1., Approximately 1 year 4 months|Progression-free survival (PFS), PFS is defined as the time from first dosing to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first., Approximately 1 year 4 months|Overall survival (OS), Overall survival (OS) defined as the time from first dosing to death., Approximately 1 year 4 months|Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Half-life, Cycles 1, 2, and 3 (each cycle is up to 21 days)|Number of participants with antidrug antibodies, Cycles 1, 2, and 3 (each cycle is up to 21 days)