The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
630
Administered orally.
Administered intravenously.
Administered intravenously.
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: Baseline through 5 years
Phase 1a: Number of Participants with DLT
Time frame: During the first 28-day cycle of LY3962673 treatment
Phase 1a: Number of Participants with DLT Equivalent Toxicities
Time frame: During the first 28-day cycle of LY3962673 treatment
Phase 1b: 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 5 years
Phase 1b: Best Overall Response (BOR)
BOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Phase 1b: Duration of Response (DOR)
DOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Phase 1b: Time to Response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Phase 1b: Disease Control Rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
City of Hope
Duarte, California, United States
RECRUITINGUniversity of California, Los Angeles (UCLA)
Los Angeles, California, United States
RECRUITINGSarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
RECRUITINGSibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGFlorida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, United States
RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITINGCommunity Health Network
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGBarbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
RECRUITING...and 42 more locations
Phase 1a: 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 5 years
Best Overall Response (BOR)
BOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Duration of Response (DOR)
DOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Time to Response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Disease Control Rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to approximately 5 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673
PK: Cmax of LY3962673
Time frame: Predose through Day 168
PK: Time to Maximum Concentration (Tmax) of LY3962673
PK: Tmax of LY3962673
Time frame: Predose through Day 168
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673
PK: AUC of LY3962673
Time frame: Predose through Day 168