Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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 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

Keywords

Locally Advanced or Metastatic Solid Tumors, Neoplasms, Cetuximab, LUNA18

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California - Davis accepting new patients
    Davis California 95616 United States
  • Renown Regional Medical Center accepting new patients
    Reno Nevada 89502 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Chugai Pharmaceutical
ID
NCT05012618
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 195 study participants
Last Updated