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

Coordination Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumor

Intratumoral Injection

Treatments

Drug: RiMO-401

Study type

Interventional

Funder types

Industry

Identifiers

NCT06182579

RiMO-401CL23-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 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 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.