The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
This is a Phase 1a/1b multicenter, open-label study in participants with select advanced or metastatic solid tumors. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
490
Intravenous
AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UT Southwestern Medical Center
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Austin Health
Heidelberg, Australia
...and 18 more locations
Phase 1a: To determine the recommended dose of LY4101174
Number of participants with dose-limiting toxicities (DLTs)
Time frame: First 2 Cycles (28 days)
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174
Number of participants with DLTs
Time frame: First 2 Cycles (28 days)
Phase 1b: To assess the antitumor activity of LY4101174 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 48 Months or 4 Years
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)
PK: Cmin of LY4101174
Time frame: First 4 cycles (56 days)
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)
PK: AUC of LY4101174
Time frame: First 4 cycles (56 days)
To evaluate the preliminary antitumor activity of LY4101174: 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 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Overall survival (OS)
OS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
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