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Sponsor decided to discontinue this study upon having LPLV.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation part (Part A) | Experimental | Patients will receive LUNA18 capsule(s) at escalated doses |
|
| Biomarker part (Part B) | Experimental | Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A |
|
| Cohort expansion part (Part C) | Experimental | Patients will receive LUNA18 capsule(s) at the recommended dose |
|
| Backfill part (Part AA) | Experimental | Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A |
|
| Dose finding part (Part D) | Experimental | Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses |
|
| Cohort expansion part (Part E) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUNA18 | Drug | LUNA18 Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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 | 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 | 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 | From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co. Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Davis | Davis | California | 95616 | United States | ||
| Beth Israel Deaconess |
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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Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose |
|
| Cetuximab | Drug | Cetuximab as a IV infusion |
|
| 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | From screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | 49546 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Abramson Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| Rhode Island Hospital-Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| NEXT Oncology | Austin | Texas | 78758 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| NEXT Virginia | Fairfax | Virginia | 22031 | United States |
| University of Wisconsin - Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Shizuoka Cancer Center | Nakatogari | Shizuoka | 411-0934 | Japan |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR | Koto-ku | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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