Advanced Solid TumorPhase 1NCT06182579
Phase I Study of RiMO-401 With Radiation in Advanced Tumors
A Phase 1 study testing RiMO-401 in people with Advanced Solid Tumor and Intratumoral Injection, run by Coordination Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Intratumoral Injection
- What is being tested?
- RiMO-401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 16 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor, Intratumoral Injection
- Being tested
- RiMO-401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiMO-401Drug
Also called Radiation
- Single intratumoral injection of RiMO-401 followed by palliative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| RiMO-401 | Experimental | • Single intratumoral injection followed by radiation Receives: Drug: RiMO-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 Days
Secondary outcomes (2)
Evaluation of Objective Response Rate (ORR)
The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1
Measured: 45 Days
Evaluation of Safety and Tolerability
Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5
Measured: 45 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start22 Feb 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- dose escalation in a 3+3 study design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordination Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182579
- Sponsor's protocol ID
- RiMO-401CL23-001
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors
- ClinicalTrials.gov ID
- NCT06182579
- Acronym / sponsor ID
- RiMO-401CL23-001
- Conditions
- Advanced Solid Tumor, Intratumoral Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Coordination Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dose escalation in a 3+3 study design
| Arm | Type | Receives |
|---|---|---|
| RiMO-401 | Experimental | Drug: RiMO-401• Single intratumoral injection followed by radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiMO-401Also: Radiation• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy | Drug | RiMO-401 |
Primary outcome
Determination of Recommended Dose
Time frame: 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
2 secondary outcomes
Evaluation of Objective Response Rate (ORR)
Time frame: 45 Days
Evaluation of Safety and Tolerability
Time frame: 45 Days
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RiMO-401 in people with Advanced Solid Tumor and Intratumoral Injection, run by Coordination Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Recommended Dose (time frame: 45 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.