The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Administered orally.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMayo Clinic
Phoenix, Arizona, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGUniversity of California, Los Angeles (UCLA)
Los Angeles, California, United States
Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: During the first cycle of LY4066434 treatment (up to 28 days)
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Time frame: Up to approximately 5 years
Best Overall Response (BOR)
BOR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Duration of Response (DOR)
DOR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Disease Control Rate (DCR)
DCR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Time to Response (TTR)
TTR as assessed by investigator per RECIST v1.1
Time frame: Up to approximately 5 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone
PK: Cmax of LY4066434
Time frame: Predose through Day 168
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents
PK: Cmax of LY4066434
Time frame: Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone
PK: Tmax of LY4066434
Time frame: Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents
PK: Tmax of LY4066434
Time frame: Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone
PK: AUC of LY4066434
Time frame: Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents
PK: AUC of LY4066434
Time frame: Predose through Day 168
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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University of Colorado Denver
Denver, Colorado, United States
NOT_YET_RECRUITINGYale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGThe University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
RECRUITINGIndiana University (IU)
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITING...and 46 more locations