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

C

Coordination Pharmaceuticals

Status and phase

Enrolling
Phase 1

Conditions

Advanced Tumors

Treatments

Drug: RiMO-301

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03444714
RiMO-CL17-001

Details and patient eligibility

About

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

Full 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)

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

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

Trial contacts and locations

2

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Central trial contact

Ze-Qi Xu, Ph.D.

Data sourced from clinicaltrials.gov

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