Phase 2 Head and Neck Cancer Trial, Recruiting NCT05838729 Sponsor: Coordination Pharmaceuticals, Inc. Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05838729
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with head and neck cancer that requires palliative radiotherapy (radiation treatment aimed at relieving symptoms rather than curing the disease)
  • People with head and neck squamous cell cancer that cannot be surgically removed, has come back, or has spread to other parts of the body — whether or not they have previously been treated with platinum-based chemotherapy, or are currently receiving a drug called pembrolizumab as a first treatment
  • People who are either already receiving a type of immunotherapy drug (pembrolizumab or nivolumab) as part of their standard care, or whose treating doctor considers them suitable to receive one of these drugs
  • People who have at least one tumour that doctors can physically access to inject the study drug (RiMO-301) and treat with radiation using the methods specified in this trial
  • People whose target tumour(s) can be measured on imaging scans, and where repeat measurements at the same location are possible
  • People whose target tumour is not in an area that has previously been irradiated, or was irradiated at least six months before the study drug injection and caused no lasting complications
  • People where the total volume of tumours being treated does not exceed 250 cm³ (up to five lesions may be treated in one patient)
  • People who have recovered from the side effects of previous cancer treatments before joining the trial (side effects must be at a mild level or resolved)
  • People who have adequate bone marrow function and adequate liver function
  • People with a life expectancy of at least 12 weeks
  • People with a general health score (ECOG scale) of 0, 1, or 2 — meaning they are able to carry out at least some daily activities independently
  • People aged 18 years or older

Who may not be able to join:

  • People who show signs of major organ failure, serious long-term illnesses unrelated to cancer, or other severe health conditions
  • People who have cancer that has spread to the brain and is causing symptoms, or cancer affecting the membranes surrounding the brain and spinal cord
  • People who have an active autoimmune disease that has needed systemic (whole-body) medical treatment within the past two years
  • People who have an active, clinically significant infection at or near the tumour site being treated
  • People who have had major surgery near the treatment area within 21 days before starting the study drug, or a minor surgical procedure within 7 days (note: placement of a port, feeding tube, or catheter does not require a waiting period)
  • People who have received any other approved or experimental cancer treatment or immunotherapy — other than pembrolizumab or nivolumab — within four weeks before the study drug injection
  • People whose tumours are located very close to, or wrapped around, major blood vessels (such as the carotid artery) or other important structures

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lawrence Feldman, MD, University of Illinois at Chicago

Phone: 630-415-5601

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Coordination Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
3 April 2023
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Determination of Recommended Dose; Evaluation of Anti-Tumor Response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov