TERMINATED

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

Conditions

Locally Advanced or Metastatic Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-10-08

Study Completion:2025-11-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05012618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Principal Investigator

Sponsor Chugai Pharmaceutical Co. Ltd

STUDY_DIRECTOR

clinical-trials@chugai-pharm.co.jp

Study Locations (Sites)

University of California - Davis

Davis, California, 95616

United States

Beth Israel Deaconess

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

Collaborators and Investigators

Sponsor: Chugai Pharmaceutical

Sponsor Chugai Pharmaceutical Co. Ltd, STUDY_DIRECTOR, clinical-trials@chugai-pharm.co.jp

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-08

Study Completion Date2025-11-13

Study Record Updates

Study Start Date2021-10-08

Study Completion Date2025-11-13

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced or Metastatic Solid Tumors