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

Stopped early · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.

Key facts

Study ID

NCT05012618

Run by

Chugai Pharmaceutical

People needed

128

Starts

2021-10-08

Expected to finish

2025-11-13

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of California - Davis — Davis, California, United States
• Beth Israel Deaconess — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Abramson Cancer Center at Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital-Comprehensive Cancer Center — Providence, Rhode Island, United States
• NEXT Oncology — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States
• Aichi Cancer Center — Nagoya, Aichi-ken, Japan
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan
• Shizuoka Cancer Center — Nakatogari, Shizuoka, Japan
• National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan
• The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan
• Osaka International Cancer Institute — Osaka, Japan

Full record on ClinicalTrials.gov

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