A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Lilly

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Solid Tumor; Colorectal Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: Cetuximab; Drug: Docetaxel; Drug: LY3499446; Drug: Abemaciclib; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04165031

17501 (Other Identifier)

J2K-MC-JZKA (Other Identifier)

2019-003070-53 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
• For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
• Participants must be willing to use highly effective birth control
• Participants must have adequate organ function
• Participants must be able to swallow capsules

Exclusion criteria

• Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
• Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
• Participants must not have cancer of the central nervous system that is not stable
• Participants must not be pregnant or breastfeeding
• Participants must not use herbal supplements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 6 patient groups

LY3499446 Phase 1 Cohort A1 High Dose

Experimental group

Description:

Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.

Treatment:

Drug: LY3499446

LY3499446 Phase 1 Cohort AO Mid Dose

Experimental group

Description:

Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.

Treatment:

Drug: LY3499446

LY3499446 Phase 1 Cohort A-2 Low Dose

Experimental group

Description:

Participants received low dose LY3499446 as oral monotherapy once daily (QD) in 21-Day cycles.

Treatment:

Drug: LY3499446

LY3499446 + Combination Drugs Phase 1

Experimental group

Description:

LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). This trial was terminated prior to initiation of combination therapy cohorts.

Treatment:

Drug: LY3499446

Drug: Abemaciclib

Drug: Erlotinib

Drug: Cetuximab

LY3499446 Monotherapy + Combination Drugs Phase 2

Experimental group

Description:

LY3499446 as oral monotherapy and LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of Phase 2 of this study.

Treatment:

Drug: LY3499446

Drug: Abemaciclib

Drug: Erlotinib

Drug: Cetuximab

Docetaxel Phase 2

Active Comparator group

Description:

Docetaxel IV infusion. The trial was terminated prior to initiation of Phase 2 of this study.

Treatment:

Drug: Docetaxel