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

Description

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

Advanced Tumors

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
Advanced Tumors
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois at Chicago, Chicago, Illinois, United States, 60612

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Coordination Pharmaceuticals, Inc.,

Study Record Dates

2024-12