NLG802 + Temozolomide for Brain Cancer

LP
Overseen ByLumos Pharma
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Lumos Pharma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in combination with temozolomide chemotherapy in children with primary brain tumors.

Are You a Good Fit for This Trial?

This trial is for children with progressive brain cancer called diffuse intrinsic pontine glioma (DIPG) or similar primary brain tumors. Participants must be able to take oral medication and meet certain health requirements set by the study team.

Inclusion Criteria

I am able to care for myself and do normal activities most of the time.
ALT ≤ 3-times upper limit of normal
Platelets ≥ 100,000/μL
See 19 more

Exclusion Criteria

Unable to swallow capsules
I currently have an infection that needs medical treatment.
Subjects who are breastfeeding or pregnant women
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • NLG802 (indoximod Prodrug)
  • Temozolomide

Trial Overview

The study tests increasing doses of NLG802 (an experimental drug that targets a specific enzyme in cancer cells) taken by mouth, combined with standard chemotherapy temozolomide. The main goal is to check safety and how the body processes these drugs.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: NLG802 indoximod prodrug in combination with temozolomideExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lumos Pharma

Lead Sponsor

Trials
5
Recruited
180+