Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05012618
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2021-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'whyStopped': 'Sponsor decided to discontinue this study upon having LPLV.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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]', 'timeFrame': 'From Cycle 0 Day 1 until Cycle 1 Day 28 (Cycle 0 is 6-9 days, and Cycle 1 is 28 days)', 'description': 'Incidence and nature of dose-limiting toxicities (DLTs)'}, {'measure': 'Safety and tolerability of LUNA18 (Adverse Events) [Part A, AA, B, C, D and E]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': '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)'}, {'measure': 'Plasma concentrations of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Plasma concentrations of LUNA18'}, {'measure': '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]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Maximum plasma concentration (Cmax) of LUNA18'}, {'measure': '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]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Time to reach maximum plasma drug concentration (Tmax) of LUNA18'}, {'measure': '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]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Area under the concentration versus time curve (AUC) of LUNA18'}, {'measure': 'Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]', 'timeFrame': 'From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible', 'description': 'Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues'}, {'measure': '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]', 'timeFrame': 'From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': '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]', 'timeFrame': 'From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)', 'description': 'Objective response, defined as CR or PR as best overall response per RECIST v1.1'}, {'measure': 'Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]', 'timeFrame': 'From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)', 'description': 'Disease control, defined as CR, PR and stable disease (SD) per RECIST v1.1'}, {'measure': 'Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]', 'timeFrame': 'From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)', 'description': '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'}, {'measure': 'Preliminary anti-tumor activity of LUNA18 [Part A, AA, B, C, D and E]', 'timeFrame': 'From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months)', 'description': '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'}, {'measure': 'Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Incidence of anti-LUNA18 antibodies'}, {'measure': 'Plasma concentrations of LUNA18 [Part B, C and E]', 'timeFrame': 'From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months)', 'description': 'Plasma concentrations of LUNA18'}, {'measure': 'Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A, AA, C, D, E]', 'timeFrame': 'From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible', 'description': 'Phosphorylation level of ERK protein (pERK) in tumor tissues biomarkers as applicable in tumor tissues'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years at time of signing informed consent form\n* ECOG performance status of 0 or 1\n* 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\n* Patients with documented RAS alterations positive solid tumors\n* Patients with measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* 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\n* Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases\n* 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)\n* Patients with a history or complication of interstitial lung disease (ILD)'}, 'identificationModule': {'nctId': 'NCT05012618', 'briefTitle': 'A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LUN101JG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation part (Part A)', 'description': 'Patients will receive LUNA18 capsule(s) at escalated doses', 'interventionNames': ['Drug: LUNA18']}, {'type': 'EXPERIMENTAL', 'label': 'Biomarker part (Part B)', 'description': 'Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A', 'interventionNames': ['Drug: LUNA18']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort expansion part (Part C)', 'description': 'Patients will receive LUNA18 capsule(s) at the recommended dose', 'interventionNames': ['Drug: LUNA18']}, {'type': 'EXPERIMENTAL', 'label': 'Backfill part (Part AA)', 'description': 'Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A', 'interventionNames': ['Drug: LUNA18']}, {'type': 'EXPERIMENTAL', 'label': 'Dose finding part (Part D)', 'description': 'Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses', 'interventionNames': ['Drug: LUNA18', 'Drug: Cetuximab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort expansion part (Part E)', 'description': 'Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose', 'interventionNames': ['Drug: LUNA18', 'Drug: Cetuximab']}], 'interventions': [{'name': 'LUNA18', 'type': 'DRUG', 'description': 'LUNA18 Capsule', 'armGroupLabels': ['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)']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Cetuximab as a IV infusion', 'armGroupLabels': ['Cohort expansion part (Part E)', 'Dose finding part (Part D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START) Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Regional Medical Center', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center at Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital-Comprehensive Cancer Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '411-0934', 'city': 'Nakatogari', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center', 'geoPoint': {'lat': 35.13526, 'lon': 138.9028}}, {'zip': '104-0045', 'city': 'Chuo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}, {'zip': '135-8550', 'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR'}, {'zip': '811-1395', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Cancer Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '541-8567', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka International Cancer Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Sponsor Chugai Pharmaceutical Co. Ltd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'clinical-trials@chugai-pharm.co.jp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}