Evaluating LUNA18 for advanced solid tumors
A Phase 1 Open-label, Dose-escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
PHASE1 · Chugai Pharmaceutical · NCT05012618
This study is testing a new treatment called LUNA18, alone or with another drug, to see if it can help people with advanced solid tumors who haven't had success with other therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chugai Pharmaceutical (industry) |
| Locations | 20 sites (Davis, California and 19 other locations) |
| Trial ID | NCT05012618 on ClinicalTrials.gov |
What this trial studies
This Phase 1 dose-escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary activity of LUNA18 in patients with locally advanced or metastatic solid tumors. Participants may receive LUNA18 alone or in combination with cetuximab, depending on their specific condition. The study will include patients with documented RAS alterations and measurable disease, focusing on those for whom standard therapies are ineffective or intolerable.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors and specific RAS alterations.
Not a fit: Patients with significant cardiovascular disease or untreated central nervous system malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited effective therapies.
How similar studies have performed: Other studies have shown promise with similar dose-escalation approaches in cancer treatment, but the specific use of LUNA18 is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Davis, California and 19 other locations
- University of California - Davis — Davis, California, United States (RECRUITING)
- Beth Israel Deaconess — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (TERMINATED)
- Renown Regional Medical Center — Reno, Nevada, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- Abramson Cancer Center at Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
- Rhode Island Hospital-Comprehensive Cancer Center — Providence, Rhode Island, United States (RECRUITING)
- NEXT Oncology — Austin, Texas, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
- University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (RECRUITING)
- Aichi Cancer Center — Nagoya, Aichi, Japan (RECRUITING)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (RECRUITING)
- Shizuoka Cancer Center — Nagaizumi, Shizuoka, Japan (RECRUITING)
- National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan (RECRUITING)
- The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (RECRUITING)
- National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (RECRUITING)
- Osaka International Cancer Institute — Osaka, Japan (RECRUITING)
Study contacts
- Study coordinator: Clinical trials information
- Email: clinical-trials@chugai-pharm.co.jp
- Phone: only use Email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced or Metastatic Solid Tumors