Phase I Study of RiMO-301 With Radiation in Advanced Tumors

Advanced Tumors Clinical Trial

Official title:

Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444714
• Other study ID #: RiMO-CL17-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Coordination Pharmaceuticals, Inc.
• Contact: Ze-Qi Xu, Ph.D.
• Phone: 6304155601
• Email: zq[@]coordinationpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes.

Condition or Disease:

Patient with advanced tumor which is clinically accessible for intratumoral injection

Intervention/Treatment:

Drug - RiMO-301

Radiation - Radiotherapy

Phase:

Phase 1

Description:

Primary Objectives:

• The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses

Secondary Objectives:

• To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief

• To characterize adverse events of RiMO-301 in patients with advanced cancers

• To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation

The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment:

• Grade 4 or greater treatment related hematologic or dermatologic toxicity

• Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (excluding nausea, vomiting or diarrhea without maximal medical intervention)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• 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 to irradiation and accessible for direct intratumoral injection

• Target tumor in region not in previously irradiated field

• Patient must have recovered from acute toxic effects (= grade 1) of previous cancer treatments prior to enrollment

• Age >18 years

• Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion

• Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing

• Patients must sign a study-specific informed consent form prior to study entry

Exclusion Criteria:

• Patients with a histological diagnosis of lymphomas and/or leukemias

• Patients may not have received chemotherapy, targeted therapies, 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

Related Conditions & MeSH terms

• Advanced Tumors

Intervention

Drug:
• RiMO-301
Drug: RiMO-301 RiMO-301 will be administered by intratumoral route as slow injection Radiotherapy Patients will receive 10 fractions of 3 Gy each over 2 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Coordination Pharmaceuticals, Inc.	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy	45 days
Secondary	clinical benefit	• To assess clinical benefit by change in tumor size and resolution of symptoms, which will be reported as response rate (%)	45 days
Secondary	adverse effect	• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE	45 days
Secondary	Maximum Plasma Concentration [Cmax]	• To evaluate Maximum Plasma Concentration [Cmax] of RiMO-301 in patients tested	45 days
Secondary	Area Under the Curve [AUC]	To evaluate Area Under the Curve [AUC] of RiMO-301 in patients tested	45 days