A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
NCT ID: NCT05012618
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
128 participants
INTERVENTIONAL
2021-10-08
2025-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation part (Part A)
Patients will receive LUNA18 capsule(s) at escalated doses
LUNA18
LUNA18 Capsule
Biomarker part (Part B)
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
LUNA18
LUNA18 Capsule
Cohort expansion part (Part C)
Patients will receive LUNA18 capsule(s) at the recommended dose
LUNA18
LUNA18 Capsule
Backfill part (Part AA)
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
LUNA18
LUNA18 Capsule
Dose finding part (Part D)
Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses
LUNA18
LUNA18 Capsule
Cetuximab
Cetuximab as a IV infusion
Cohort expansion part (Part E)
Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose
LUNA18
LUNA18 Capsule
Cetuximab
Cetuximab as a IV infusion
Interventions
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LUNA18
LUNA18 Capsule
Cetuximab
Cetuximab as a IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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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
Countries
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Other Identifiers
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LUN101JG
Identifier Type: -
Identifier Source: org_study_id