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

  • Interventional
  • Not Recruiting
  • NCT03444714
Eligibility Details Visit Clinicaltrials.gov

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

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

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)

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03444714

IRB#IRB17-1311

Lead SponsorRimo Therapeutics Inc.

Lead PhysicianSteven Chmura

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting