臨床研究等提出・公開システム

A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors (J5Q-OX-JRDA)

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors (J5Q-OX-JRDA)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Jan. 08, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

- Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
- Have measurable disease per RECIST 1.1
- Have an ECOG performance status of<=1
- Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
- Must be able to swallow tablets
- Participants with asymptomatic or treated CNS disease may be eligible

- Have known active CNS metastases and/or carcinomatous meningitis
- Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, hearing loss, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
- Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
- Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) or untreated HIV infection
- Have other active malignancy unless in remission with life expectancy greater than 2 years.
- Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

Both

Refer to 7(5)

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.
Other Names:
Folinic Acid
DRUG: Irinotecan
Administered intravenously.
DRUG: 5Fluorouracil
Administered intravenously.
DRUG: Carboplatin
Administered intravenously.
DRUG: Cisplatin
Administered intravenously.
DRUG: Pemetrexed
Administered intravenously.
DRUG: Pembrolizumab
Administered intravenously.

(Study Arms)
Experimental: LY4066434 Monotherapy Dose Escalation
Escalating doses of LY4066434 administered orally.
Interventions:
Drug: LY4066434.
Experimental: LY4066434 Dose Optimization
LY4066434 administered orally either alone or with another investigational agent.
Interventions:
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

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 [Time Frame: Up to approximately 5 years]
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

+81-3-3520-0111

Nov. 18, 2024

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States/Belgium/China/France/Germany/Italy/Spain/Taiwan