The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
421
City of Hope
Duarte, California, United States
NOT_YET_RECRUITINGUniversity of California, Los Angeles (UCLA)
Santa Monica, California, United States
RECRUITINGStanford University Medical Center
Stanford, California, United States
RECRUITINGBiogenix Molecular, LLC
Miami, Florida, United States
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
Time frame: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496
Time frame: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Time frame: From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks
Phase 1a Dose Escalation and Optimization: ORR: Percentage of Participants with Best Response of CR or PR
Time frame: From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks
Phase 1a Dose Escalation: Absorbed Dose Estimates (Gray (Gy)) of LY4257496 in Normal Organs
Time frame: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days
Phase 1a Dose Escalation and Optimization: Absorbed Dose Estimates (Gy) of LY4257529 in Normal Organs
Time frame: From end of injection at Screening, and at Day 30 through 1 day after injection
Phase 1a Dose Escalation Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY4257496
Time frame: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days
Phase 1a Dose Escalation and Optimization PK: Cmax of LY4257529
Time frame: From end of injection through 1 day after injection
Phase 1a Dose Escalation PK: Area Under the Curve (AUC) of LY4257496
Time frame: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days
Phase 1a Dose Escalation and Optimization PK: AUC of LY4257529
Time frame: From end of injection through 1 day after injection
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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Moffitt
Tampa, Florida, United States
NOT_YET_RECRUITINGEmory University School of Medicine - Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBarbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGBAMF Health Inc.
Grand Rapids, Michigan, United States
RECRUITING...and 20 more locations