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

Sponsor
Goethe University
Study ID
NCT07161310
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urolithin A — DIETARY_SUPPLEMENT
    Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Placebo — DIETARY_SUPPLEMENT
    Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Bio specimens — OTHER
    Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Study Details

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®).

Key Dates

First listed
Sep 8, 2025
Start date
Jan 2, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Urolithin A
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in the composition of circulating lymphocytes [ Time Frame: From enrollment to the end of urolithin A intake at 8-9 weeks ]

Central Contacts

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