Locally Advanced or Metastatic Solid TumorsPhase 1NCT05012618
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
A Phase 1 study testing LUNA18 and Cetuximab in people with Locally Advanced or Metastatic Solid Tumors, run by Chugai Pharmaceutical at 20 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- LUNA18 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 8 Oct 2021to 13 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States13 sites
NEXT Oncology
Austin, Texas, 78758
Beth Israel Deaconess
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of California - Davis
Davis, California, 95616
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
NEXT Virginia
Fairfax, Virginia, 22031
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53792
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Rhode Island Hospital-Comprehensive Cancer Center
Providence, Rhode Island, 02903
Renown Regional Medical Center
Reno, Nevada, 89502
Japan7 sites
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-0934
Osaka International Cancer Institute
Osaka, 541-8567
About this study
Official title: 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
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.
- Being tested
- LUNA18, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUNA18Drug
LUNA18 Capsule
CetuximabDrug
Cetuximab as a IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation part (Part A) | Experimental | Patients will receive LUNA18 capsule(s) at escalated doses Receives: Drug: LUNA18 |
| Biomarker part (Part B) | Experimental | Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A Receives: Drug: LUNA18 |
| Cohort expansion part (Part C) | Experimental | Patients will receive LUNA18 capsule(s) at the recommended dose Receives: Drug: LUNA18 |
| Backfill part (Part AA) | Experimental | Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A Receives: Drug: LUNA18 |
| Dose finding part (Part D) | Experimental | Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses Receives: Drug: LUNA18; Drug: Cetuximab |
| Cohort expansion part (Part E) | Experimental | Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose Receives: Drug: LUNA18; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of LUNA18 (Dose-limiting toxicities) when administered as a single agent [Part A] and in combination with other anti-cancer drugs [Part D]
Incidence and nature of dose-limiting toxicities (DLTs)
Measured: From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)
Safety and tolerability of LUNA18 (Adverse Events) [Part A, AA, B, C, D and E]
Incidence, nature and severity of adverse events, with severity determined per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Plasma concentrations of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Plasma concentrations of LUNA18
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Maximum plasma concentration (Cmax) of LUNA18
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Time to reach maximum plasma drug concentration (Tmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Time to reach maximum plasma drug concentration (Tmax) of LUNA18
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Area under the concentration versus time curve (AUC) of LUNA18
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]
Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues
Measured: From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part B, C] and in combination with other anti-cancer drugs [Part E]
Objective response, defined as a confirmed complete response (CR) or partial response (PR) as best overall response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Secondary outcomes (7)
Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part A, Part AA] and in combination with other anti-cancer drugs [Part D]
Objective response, defined as CR or PR as best overall response per RECIST v1.1
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Disease control, defined as CR, PR and stable disease (SD) per RECIST v1.1
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Duration of response (DoR), defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Progression free survival (PFS), defined as the time from the first study treatment to the first occurrence of progression per RECIST v1.1 or death from any cause, whichever occurs first
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]
Incidence of anti-LUNA18 antibodies
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Plasma concentrations of LUNA18 [Part B, C and E]
Plasma concentrations of LUNA18
Measured: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A, AA, C, D, E]
Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues
Measured: From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start8 Oct 2021
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Why it stopped: Sponsor decided to discontinue this study upon having LPLV.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012618
- Sponsor's protocol ID
- LUN101JG
- Status last verified
- Dec 2025
- First submitted
- 3 Aug 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05012618
- Acronym / sponsor ID
- LUN101JG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to discontinue this study upon having LPLV.
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose escalation part (Part A) | Experimental | Drug: LUNA18Patients will receive LUNA18 capsule(s) at escalated doses |
| Biomarker part (Part B) | Experimental | Drug: LUNA18Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A |
| Cohort expansion part (Part C) | Experimental | Drug: LUNA18Patients will receive LUNA18 capsule(s) at the recommended dose |
| Backfill part (Part AA) | Experimental | Drug: LUNA18Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A |
| Dose finding part (Part D) | Experimental | Drug: LUNA18, Drug: CetuximabPatients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses |
| Cohort expansion part (Part E) | Experimental | Drug: LUNA18, Drug: CetuximabPatients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUNA18LUNA18 Capsule | Drug | Backfill part (Part AA), Biomarker part (Part B), Cohort expansion part (Part C), Cohort expansion part (Part E), Dose escalation part (Part A), Dose finding part (Part D) |
| CetuximabCetuximab as a IV infusion | Drug | Cohort expansion part (Part E), Dose finding part (Part D) |
Primary outcome
Safety and tolerability of LUNA18 (Dose-limiting toxicities) when administered as a single agent [Part A] and in combination with other anti-cancer drugs [Part D]
Time frame: From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)
Incidence and nature of dose-limiting toxicities (DLTs)
Safety and tolerability of LUNA18 (Adverse Events) [Part A, AA, B, C, D and E]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Incidence, nature and severity of adverse events, with severity determined per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Plasma concentrations of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Plasma concentrations of LUNA18
Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Maximum plasma concentration (Cmax) of LUNA18
Time to reach maximum plasma drug concentration (Tmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Time to reach maximum plasma drug concentration (Tmax) of LUNA18
Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Area under the concentration versus time curve (AUC) of LUNA18
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]
Time frame: From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues
Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part B, C] and in combination with other anti-cancer drugs [Part E]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Objective response, defined as a confirmed complete response (CR) or partial response (PR) as best overall response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
7 secondary outcomes
Preliminary anti-tumor activity of LUNA18 when administered as a single agent [Part A, Part AA] and in combination with other anti-cancer drugs [Part D]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)
Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Plasma concentrations of LUNA18 [Part B, C and E]
Time frame: From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A, AA, C, D, E]
Time frame: From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Results and safety
The study was stopped early (reason given: Sponsor decided to discontinue this study upon having LPLV.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LUNA18 and Cetuximab in people with Locally Advanced or Metastatic Solid Tumors, run by Chugai Pharmaceutical at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided to discontinue this study upon having LPLV.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of LUNA18 (Dose-limiting toxicities) when administered as a single agent [Part A] and in combination with other anti-cancer drugs [Part D] (time frame: From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.