A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Summary

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.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

DRUG

Irinotecan

Administered intravenously.

DRUG

5Fluorouracil

Administered intravenously.

DRUG

Carboplatin

Administered intravenously.

DRUG

Cisplatin

Administered intravenously.

DRUG

Pemetrexed

Administered intravenously.

DRUG

Pembrolizumab

Administered intravenously.

DRUG

LY4066434.

Administered orally.

DRUG

Cetuximab

Administered intravenously.

DRUG

Nab paclitaxel

Administered intravenously.

DRUG

Gemcitabine

Administered intravenously.

DRUG

Oxaliplatin

Administered intravenously.

DRUG

Leucovorin

Administered intravenously.

Sponsors & Collaborators

• Eli Lilly and Company

  lead INDUSTRY

Principal Investigators

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-21

Primary Completion

2030-01-31

Completion

2030-01-31

FDA Drug

Yes

Countries

• United States
• Belgium
• China
• France
• Germany
• Italy
• Japan
• Spain
• Taiwan

Study Locations