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

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Locally Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Davis

University of California - Davis, Davis, California, United States, 95616

Boston

Beth Israel Deaconess, Boston, Massachusetts, United States, 02215

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Grand Rapids

South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, United States, 49546

Reno

Renown Regional Medical Center, Reno, Nevada, United States, 89502

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Philadelphia

Abramson Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States, 19106

Providence

Rhode Island Hospital-Comprehensive Cancer Center, Providence, Rhode Island, United States, 02903

Austin

NEXT Oncology, Austin, Texas, United States, 78758

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Chugai Pharmaceutical,

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

Study Record Dates

2026-05-16