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Safety of Navoximod and NLG802 With Stereotactic Body Radiotherapy (SBRT) Treatment of Advanced Solid Tumors

NCT05469490 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-09-30

No results posted yet for this 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.

Conditions

Interventions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

SBRT is specialize radiation that is effective for ablating tumors at primary and metastatic locations that increases antigen uptake/processing/presentation.

DRUG

navoximod

A small molecule inhibitor with potent inhibition of IDO1 enzymatic activity as shown both in vitro and in vivo. As the main function of IDO1 is the regulation of acquired immune tolerance, and its expression in tumor- and dendritic cells in tumor draining lymph nodes negatively correlates with cancer prognosis and survival, navoximod-mediated IDO1 inhibition may restore immune reactivity towards tumors.

DRUG

NLG802 (indoximod Prodrug)

An anti-tumor immunomodulator with the active ingredient of 1-methyl-D-tryptophan (NSC- 721782, 1-MT), which is an inhibitor of the indoleamine 2,3-dioxygenase (IDO) pathway that increases the bioavailability of indoximod by leveraging existing mechanisms of absorption, increasing the exposure of indoximod.

Sponsors & Collaborators

  • Lumos Pharma

    collaborator INDUSTRY

  • Luke, Jason, MD

    lead OTHER

Principal Investigators

  • Adam Olson, MD, MS · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-08-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469490 on ClinicalTrials.gov