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

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ClinicalTrials.gov Identifier: NCT03444714
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Rimo Therapeutics Inc.

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


Condition or disease Intervention/treatment Phase
Advanced Tumors Drug: RiMO-301 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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 3 + 3 dose escalation study design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: RiMO-301+Radiotherapy
3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study
Drug: RiMO-301

Drug: RiMO-301 RiMO-301 will be administered by intratumoral route as slow injection

Radiotherapy Patients will receive 10 fractions of 3 Gy each over 2 weeks

Other Name: Radiotherapy




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 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 :
  1. clinical benefit [ Time Frame: 45 days ]
    • To assess clinical benefit by change in tumor size and resolution of symptoms, which will be reported as response rate (%)

  2. adverse effect [ Time Frame: 45 days ]
    • To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE

  3. Maximum Plasma Concentration [Cmax] [ Time Frame: 45 days ]
    • To evaluate Maximum Plasma Concentration [Cmax] of RiMO-301 in patients tested

  4. Area Under the Curve [AUC] [ Time Frame: 45 days ]
    To evaluate Area Under the Curve [AUC] of RiMO-301 in patients tested



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444714


Contacts
Contact: Ze-Qi Xu, Ph.D. 6304155601 zq@rimorx.com

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Grace Rivera    773-702-4193    grivera1@bsd.uchicago.edu   
Sponsors and Collaborators
Rimo Therapeutics Inc.
University of Chicago
Investigators
Principal Investigator: Jason Luke, M.D. University of Chicago

Responsible Party: Rimo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03444714     History of Changes
Other Study ID Numbers: RiMO-CL17-001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared due to confidentiality agreements

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rimo Therapeutics Inc.:
intratumoral