Advanced Solid Tumor, Intratumoral Injection
Conditions
Brief summary
This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.
Detailed description
Primary Objectives: • To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5 Secondary Objectives: * To determine clinical response of RiMO-401 with palliative radiotherapy * To characterize adverse events of RiMO-401 in patients with advanced cancers * To characterize the pharmacokinetics of RiMO-401 with palliative radiation The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.
Interventions
DRUGRiMO-401
• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy
Sponsors
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
dose escalation in a 3+3 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 for intratumoral injection * Target tumor in region not in the field that was irradiated within the past six months * Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment * Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment * Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion * ECOG score of 0-1 * Have a life expectancy of at least 12 weeks * Have adequate bone marrow reserve and adequate liver function * Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures * Patients must sign a study-specific informed consent form prior to study entry * Age 18 years or older.
Exclusion criteria
* Patients with a histological diagnosis of lymphomas and/or leukemias * Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected * Patients may not have received chemotherapy, targeted therapies, immunotherapies, 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 * Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Recommended Dose | 45 Days | The dose limiting toxicities of RiMO-401 with palliative radiation, as assessed by CTCAEv5, will not be observed in 33% or more patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Objective Response Rate (ORR) | 45 Days | The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1 |
| Evaluation of Safety and Tolerability | 45 Days | Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Maximum Plasma Concentration (Cmax) | 8 Days | Plasma concentrations of RiMO-401 will be measured until 8 days after administration |
| Evaluation of Area Under the Curve (AUC) | 8 Days | Plasma concentrations of RiMO-401 will be measured until 8 days after administration |
Countries
United States
Outcome results
None listed