A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Launched by CHUGAI PHARMACEUTICAL · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial, called LUNA18, is looking at a new treatment for patients with locally advanced or metastatic solid tumors, which are types of cancer that have spread from their original site. The trial is in its early stages (Phase 1) and aims to find out how safe the treatment is, how it works in the body, and if it shows any signs of being effective. Participants will receive LUNA18 alone or alongside other cancer treatments. The study is currently recruiting patients aged 18 and older who have specific types of cancer that haven't responded to standard treatments or for which no effective treatments are available.

To be eligible for this trial, patients should have a confirmed diagnosis of an advanced or recurrent solid tumor and meet certain health criteria. For example, they should be well enough to participate (ECOG performance status of 0 or 1) and have measurable disease. However, some patients may not qualify, such as those with certain heart conditions or active central nervous system issues. If eligible, participants can expect to undergo tests and monitoring during the study to ensure their safety. Overall, this trial offers a potential new option for patients whose cancer is difficult to treat.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion 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)