Advanced Tumors
Conditions
Keywords
intratumoral
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)
Interventions
DRUGRiMO-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
Sponsors
University of Chicago
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 + 3 dose escalation study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 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
| Measure | Time frame | Description |
|---|---|---|
| clinical benefit | 45 days | • To assess clinical benefit by change in tumor size and resolution of symptoms, which will be reported as response rate (%) |
| adverse effect | 45 days | • To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE |
| Maximum Plasma Concentration [Cmax] | 45 days | • To evaluate Maximum Plasma Concentration \[Cmax\] of RiMO-301 in patients tested |
| Area Under the Curve [AUC] | 45 days | To evaluate Area Under the Curve \[AUC\] of RiMO-301 in patients tested |
Countries
United States
Outcome results
None listed