A phase 1 study of LUNA18 in patients with locally advanced or metastatic solid tumors

JRCT ID: jRCT2031210282

Registered date:27/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumors
• Date of first enrollment: 27/10/2021
• Target sample size: 195
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

LUNA18: Oral administration
Cetuximab: Intravenous administration

Outcome(s)

Primary Outcome

Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics
Observation/test

Secondary Outcome

Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics
Observation/test

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age >= 18 years at time of signing informed consent form
- ECOG performance status of 0 or 1
- Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
- Patients with documented RAS alterations positive solid tumors
- Patients with measurable disease per RECIST v1.1

Exclude criteria

- Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months
- Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
- Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)
- Patients with a history or complication of interstitial lung disease (ILD)

Related Information

• Primary Sponsor: Jane Royalty
• Secondary ID(s): NCT05012618