New combo therapy targets Hard-to-Treat tumors
NCT ID NCT03444714
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called RiMO-301, injected directly into tumors, along with standard radiation. It involved 32 people with advanced cancers that could not be cured. The main goal was to find a safe dose and check for any early signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RiMO-301 (a drug injected directly into the tumor)
- What this could lead to
- If it works, this could point toward a new way to treat advanced tumors by combining a targeted drug with radiation.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not effectiveness. It may not lead to a proven treatment, and side effects are unknown.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
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Apr 2018
- 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 to irradiation and accessible for direct intratumoral injection * Target tumor in region not in previously irradiated field * Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment * Age \>18 years * Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion * Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing * Patients must sign a study-specific informed consent form prior to study entry Exclusion Criteria: * Patients with a histological diagnosis of lymphomas and/or leukemias * Patients may not have received chemotherapy, targeted therapies, 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
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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 Chicago Medical Center
Chicago, Illinois, 60637, United States
-
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
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Other studies related to the condition(s) this trial covers.
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- New injectable drug tested for safety in Hard-to-Treat solid tumors
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