Phase I Study of RiMO-301 With Radiation in Advanced Tumors

Phase 1

Recruiting

Brief Summary: 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

Detailed Description: Primary Objectives:

• The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses

Secondary Objectives:

* To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief

* To characterize adverse events of RiMO-301 in patients with advanced cancers

* To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation

The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment:

* Grade 4 or greater treatment related hematologic or dermatologic toxicity

* Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (excluding nausea, vomiting or diarrhea without maximal medical intervention)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
RiMO-301+Radiotherapy	RiMO-301	3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	45 days	• 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 Outcome Measures

Name	Time	Method
clinical benefit	45 days	• To assess clinical benefit by change in tumor size and resolution of symptoms, which will be reported as response rate (%)
adverse effect	45 days	• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Maximum Plasma Concentration [Cmax]	45 days	• To evaluate Maximum Plasma Concentration \[Cmax\] of RiMO-301 in patients tested
Area Under the Curve [AUC]	45 days	To evaluate Area Under the Curve \[AUC\] of RiMO-301 in patients tested

Locations (2): University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States