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A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

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ClinicalTrials.gov Identifier: NCT05012618
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Brief 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 in patients with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors Drug: LUNA18 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 8, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Arm Intervention/treatment
Experimental: Dose escalation part (Part A)
Patients will receive LUNA18 capsule(s) at escalated doses
Drug: LUNA18
LUNA18 Capsule

Experimental: Biomarker part (Part B)
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Drug: LUNA18
LUNA18 Capsule

Experimental: Cohort expansion part (Part C)
Patients will receive LUNA18 capsule(s) at the recommended dose
Drug: LUNA18
LUNA18 Capsule




Primary Outcome Measures :
  1. Safety and tolerability of LUNA18 (Dose-limiting toxicities) [Part A] [ 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)

  2. Safety and tolerability of LUNA18 (Adverse Events) [Part A, B and C] [ 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)

  3. Plasma concentrations of LUNA18 [Part A] [ 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

  4. Maximum plasma concentration (Cmax) of LUNA18 [Part A] [ 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

  5. Time to reach maximum plasma drug concentration (Tmax) of LUNA18 [Part A] [ 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

  6. Area under the concentration versus time curve (AUC) of LUNA18 [Part A] [ 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

  7. 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

  8. Preliminary anti-tumor activity of LUNA18 [Part C] [ 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)


Secondary Outcome Measures :
  1. Preliminary anti-tumor activity of LUNA18 [Part A] [ Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months) ]
    Objective response, defined as CR or PR as best overall response per RECIST v1.1

  2. Preliminary anti-tumor activity of LUNA18 [Part A, B and C] [ Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months) ]
    Disease control, defined as CR, PR and stable disease (SD) per RECIST v1.1

  3. Preliminary anti-tumor activity of LUNA18 [Part A, B and C] [ Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months) ]
    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

  4. Preliminary anti-tumor activity of LUNA18 [Part A, B and C] [ Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first (up to approximately 43 months) ]
    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

  5. Anti-drug antibody to LUNA18 [Part A, B and C] [ 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 of anti-LUNA18 antibodies

  6. Plasma concentrations of LUNA18 [Part B and C] [ 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

  7. Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A and C] [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05012618


Contacts
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Contact: Clinical trials information only use Email clinical-trials@chugai-pharm.co.jp

Locations
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United States, Texas
NEXT Oncology Recruiting
Austin, Texas, United States, 78758
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Japan
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
National Cancer Center Hospital Recruiting
Chuo-Ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
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Study Director: Sponsor Chugai Pharmaceutical Co. Ltd clinical-trials@chugai-pharm.co.jp
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Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT05012618    
Other Study ID Numbers: LUN101JG
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms