CLINICAL TRIAL / NCT06182579
Phase I Study of RiMO-401 With Radiation in Advanced Tumors
- Interventional
- Recruiting
- NCT06182579
Contact Information
- Saleh Fadel
Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors
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.
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.
Gender
All
Age Group
18 Years and up
Accepting 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.
- Solid Tumors