The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
575
HonorHealth
Scottsdale, Arizona, United States
RECRUITINGUniversity of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGSouth Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
RECRUITINGNYU Langone Health - Long Island
Mineola, New York, United States
RECRUITINGNew York University (NYU) Clinical Cancer Center
New York, New York, United States
RECRUITINGDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGThe Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGThe University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITING...and 14 more locations
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)
Number of participants with dose-limiting toxicities (DLTs)
Time frame: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab
Number of participants with DLTs
Time frame: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin
Number of participants with DLTs
Time frame: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab
Number of participants with DLTs
Time frame: 1 Cycle (21 or 28 days)
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Up to Approximately 60 Months or 5 Years
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
ORR per RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Up to Approximately 60 Months or 5 Years
To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)
PK: Cmin of Sofe-M (LY4170156)
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin
PK: Cmin of Sofe-M (LY4170156)
Time frame: First 4 Cycles (Approximately 84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab
PK: Cmin of Sofe-M (LY4170156)
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)
PK: AUC of Sofe-M (LY4170156)
Time frame: First 4 Cycles (84 days)
To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)
PRO-CTCAE of Sofe-M (LY4170156)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab
DOR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab
TTR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab
PFS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years]
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab
DCR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 60 Months or 5 Years