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2024-10-21
2030-01
2030-01
750
NCT06607185
Eli Lilly and Company
Eli Lilly and Company
INTERVENTIONAL
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-09-19 | N/A | 2025-06-18 |
2024-09-19 | N/A | 2025-06-19 |
2024-09-23 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: LY4066434 Monotherapy Dose Escalation Escalating doses of LY4066434 administered orally. | DRUG: LY4066434.
|
| EXPERIMENTAL: LY4066434 Dose Optimization LY4066434 administered orally either alone or with another investigational agent. | DRUG: LY4066434.
DRUG: Cetuximab
DRUG: Nab paclitaxel
DRUG: Gemcitabine
DRUG: Oxaliplatin
DRUG: Leucovorin
DRUG: Irinotecan
DRUG: 5Fluorouracil
DRUG: Carboplatin
DRUG: Cisplatin
DRUG: Pemetrexed
DRUG: Pembrolizumab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) | 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. | Up to approximately 5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR as assessed by investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) | Up to approximately 5 years |
| Best Overall Response (BOR) | BOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
| Duration of Response (DOR) | DOR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
| Disease Control Rate (DCR) | DCR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
| Time to Response (TTR) | TTR as assessed by investigator per RECIST v1.1 | Up to approximately 5 years |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 Alone | PK: Cmax of LY4066434 | Predose through Day 168 |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4066434 in Combination With Other Agents | PK: Cmax of LY4066434 | Predose through Day 168 |
| PK: Time to Maximum Concentration (Tmax) of LY4066434 Alone | PK: Tmax of LY4066434 | Predose through Day 168 |
| PK: Time to Maximum Concentration (Tmax) of LY4066434 in Combination With Other Agents | PK: Tmax of LY4066434 | Predose through Day 168 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 Alone | PK: AUC of LY4066434 | Predose through Day 168 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4066434 in Combination With Other Agents | PK: AUC of LY4066434 | Predose through Day 168 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Phone Number: 13176154559 Email: clinical_inquiry_hub@lilly.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
