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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182579
• Other study ID #: RiMO-401CL23-001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2024
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Coordination Pharmaceuticals, Inc.
• Contact: Ze-Qi Xu, Ph.D.
• Phone: 630-415-5601
• Email: ZQ[@]COORDINATIONPHARMA.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• RiMO-401
• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Coordination Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of Maximum Plasma Concentration (Cmax)	Plasma concentrations of RiMO-401 will be measured until 8 days after administration	8 Days
Other	Evaluation of Area Under the Curve (AUC)	Plasma concentrations of RiMO-401 will be measured until 8 days after administration	8 Days
Primary	Determination of Recommended Dose	The dose limiting toxicities of RiMO-401 with palliative radiation, as assessed by CTCAEv5, will not be observed in 33% or more patients	45 Days
Secondary	Evaluation of Objective Response Rate (ORR)	The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1	45 Days
Secondary	Evaluation of Safety and Tolerability	Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5	45 Days