Clinical trial · Interventional
Phase I Study of RiMO-301 With Radiation in Advanced Tumors
Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes. Condition or Disease: Patient with advanced tumor which is clinically accessible for intratumoral injection Intervention/Treatment: Drug - RiMO-301 Radiation - Radiotherapy Phase: Phase 1
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RiMO-301 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RiMO-301+Radiotherapy
- description
- 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study
- interventionNames
- Drug: RiMO-301
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 45 days
- description
- • To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy
Secondary outcomes (4)
- measure
- clinical benefit
- timeFrame
- 45 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available