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Trial record 1 of 1 for:    NCT03444714
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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 : July 8, 2019
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Rimo Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE April 10, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • 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 (%)
  • adverse effect [ Time Frame: 45 days ]
    • To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
  • Maximum Plasma Concentration [Cmax] [ Time Frame: 45 days ]
    • To evaluate Maximum Plasma Concentration [Cmax] of RiMO-301 in patients tested
  • Area Under the Curve [AUC] [ Time Frame: 45 days ]
    To evaluate Area Under the Curve [AUC] of RiMO-301 in patients tested
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of RiMO-301 With Radiation in Advanced Tumors
Official Title  ICMJE Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
3 + 3 dose escalation study design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Tumors
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: RiMO-301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ze-Qi Xu, Ph.D. 6304155601 zq@rimorx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03444714
Other Study ID Numbers  ICMJE RiMO-CL17-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will not be shared due to confidentiality agreements
Responsible Party Rimo Therapeutics Inc.
Study Sponsor  ICMJE Rimo Therapeutics Inc.
Collaborators  ICMJE University of Chicago
Investigators  ICMJE Not Provided
PRS Account Rimo Therapeutics Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP