Experimental cancer combo trial ends early – only 5 patients treated
NCT ID NCT06182579
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a drug called RiMO-401, injected directly into tumors and followed by radiation, in people with advanced cancers that had not responded to standard treatments. Only 5 patients were enrolled before the study was terminated. The main goal was to find a safe dose and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RiMO-401 (a drug injected into the tumor, then activated by radiation)
- What this could lead to
- If it works, this could point toward a way to make radiation more effective for hard-to-treat tumors.
- What could go wrong
- This was a very early, small trial that was terminated early, so we have little data. It may not work or may cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
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Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of advanced or metastatic cancer not amenable to curative therapy * Lesion that is amenable to palliative radiotherapy * Lesion that is technically feasible for intratumoral injection * Target tumor in region not in the field that was irradiated within the past six months * Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment * Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment * Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion * ECOG score of 0-1 * Have a life expectancy of at least 12 weeks * Have adequate bone marrow reserve and adequate liver function * Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures * Patients must sign a study-specific informed consent form prior to study entry * Age 18 years or older. Exclusion Criteria: * Patients with a histological diagnosis of lymphomas and/or leukemias * Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected * Patients may not have received chemotherapy, targeted therapies, immunotherapies, biologic response modifiers and/or hormonal therapy within the last 14 days * Ongoing clinically significant infection at or near the incident lesion * Major surgery over the target area (excluding placement of vascular access) \<21 days from beginning of the study drug or minor surgical procedures \<7 days * Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study * Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial * Pregnant and nursing women * Patients with a target lesion located in a previously irradiated field * Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
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