Phase I Study of RiMO-401 With Radiation in Advanced Tumors

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
RiMO-401	RiMO-401	• Single intratumoral injection followed by radiation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of Safety and Tolerability	45 Days	Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5
Evaluation of Objective Response Rate (ORR)	45 Days	The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1

Recruitment & Eligibility