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Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

NCT07161310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-08

No results posted yet for this study

Summary

The aim of this clinical study is to learn more about the effects of urolithin A (MitoPure®) on the immune system of cancer patients receiving immune checkpoint inhibitor-based therapies. Any effects will be compared with patients who take a placebo instead of urolithin A (MitoPure®).

Conditions

Interventions

DIETARY_SUPPLEMENT

Urolithin A

Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.

DIETARY_SUPPLEMENT

Placebo

Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.

OTHER

Bio specimens

Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Sponsors & Collaborators

  • Amazentis SA

    collaborator INDUSTRY

  • Georg-Speyer-Haus

    collaborator UNKNOWN

  • Goethe University

    lead OTHER

Principal Investigators

  • Fabian Acker, MD · Goethe Universität

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT07161310 on ClinicalTrials.gov