Stereotactic Body Radiotherapy (SBRT) for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Solid Tumors, Advanced Solid Tumors+1 More
Stereotactic Body Radiotherapy (SBRT) - Radiation
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This early phase trial proposes to study of stereotactic body radiation therapy (SBRT) with navoximod and NLG802, a prodrug of indoximod. Combinations of immune-oncology (IO) agents with complementary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy. Radiation therapy induces immunogenic cell death, increases production of tumor specific antigens, enhances TH cell functioning, and modulates immunosuppressive cell populations such as T regulatory cells and myeloid derived suppressor cells.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 1 year (patient), up to 4 years (cohort)

Year 4
Adverse Events (AE) and Serious Adverse Events (SAE)
Objective response rate (ORR)
Up to 4 years
Local control by irRECIST
Local control per RECIST version 1.1
Overall survival (OS)
Progression-free survival (PFS)
Day 90
Recommended Phase 2 Dose (RP2D)

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

1 Treatment Group

Stereotactic Body Radiotherapy (SBRT) + NLG802 and navoximod
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic Body Radiotherapy (SBRT) · No Placebo Group · Phase 1

Stereotactic Body Radiotherapy (SBRT) + NLG802 and navoximodExperimental Group · 3 Interventions: navoximod, Stereotactic Body Radiotherapy (SBRT), NLG802 (indoximod Prodrug) · Intervention Types: Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2017
Completed Phase 3
~520

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year (patient), up to 4 years (cohort)
Closest Location: UPMC Hillman Cancer Center · Pittsburgh, PA
Photo of UPMC Hillman Cancer Center 1Photo of UPMC Hillman Cancer Center 2Photo of UPMC Hillman Cancer Center 3
2007First Recorded Clinical Trial
15 TrialsResearching Solid Tumors, Advanced Solid Tumors
62 CompletedClinical Trials

Who is running the clinical trial?

Lumos PharmaIndustry Sponsor
3 Previous Clinical Trials
124 Total Patients Enrolled
Luke, Jason, MDLead Sponsor
Adam Olson, MD, MSPrincipal InvestigatorUPMC Hillman Cancer Center

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histologically confirmed advanced solid tumor for which curative treatment is not available.
You have undergone appropriate standard of care treatment options.
You have a performance status of ≤ 1.
You have an absolute neutrophil count (ANC) of at least 1,500/μL.
You have a hemoglobin level of at least 8 g/dL.
You have a serum creatinine concentration of 1.5 times the institutional upper limit of normal (ULN) or a creatinine clearance of 50 mL/min or greater.
You have serum total bilirubin ≤1.5× institutional ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.