A Phase 1 interventional study of LUNA18 and Cetuximab in Locally Advanced or Metastatic Solid Tumors, sponsored by Chugai Pharmaceutical. Terminated at 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Chugai Pharmaceutical · Phase 1, Interventional, and Treatment
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.
Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive LUNA18 capsule(s) at escalated doses
Drug: LUNA18
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Drug: LUNA18
Patients will receive LUNA18 capsule(s) at the recommended dose
Drug: LUNA18
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Drug: LUNA18
Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses
Drug: LUNA18 · Drug: Cetuximab
Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose
Drug: LUNA18 · Drug: Cetuximab
LUNA18 Capsule
Cetuximab as a IV infusion
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)
Time frame: 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)
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 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]
Plasma concentrations of LUNA18
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 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
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 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
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 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
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 B]
Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues
Time frame: 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)
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 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
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]
Disease control, defined as CR, PR and stable disease (SD) per RECIST v1.1
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]
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
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]
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
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]
Incidence of anti-LUNA18 antibodies
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]
Plasma concentrations of LUNA18
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]
Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues
Time frame: From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
Plan to share: 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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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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