Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors

Study Overview
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Brief Summary
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This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.

Detailed Description
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Primary Objectives: • To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5 Secondary Objectives: To determine clinical response of RiMO-401 with palliative radiotherapy To characterize adverse events of RiMO-401 in patients with advanced cancers To characterize the pharmacokinetics of RiMO-401 with palliative radiation The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.

Official Title
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Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors

Conditions
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Advanced Solid Tumor, Intratumoral Injection

Intervention / Treatment
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* Drug: RiMO-401


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: dose escalation in a 3+3 study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RiMO-401<br>• Single intratumoral injection followed by radiation | Drug: RiMO-401<br>* • Single intratumoral injection of RiMO-401 followed by palliative radiotherapy<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Recommended Dose | The dose limiting toxicities of RiMO-401 with palliative radiation, as assessed by CTCAEv5, will not be observed in 33% or more patients | 45 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Objective Response Rate (ORR) | The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1 | 45 Days | 
| Evaluation of Safety and Tolerability | Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5 | 45 Days |