Mushroom-Derived compound joins forces with radiation and immunotherapy to fight advanced cancers
NCT ID NCT07267234
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of PRaG-1 Cordycepin Tablets (from a fungus), radiation therapy, immune-boosting injections, and immunotherapy drugs in 65 adults with advanced solid tumors who have no standard treatment options. The goal is to see if this mix improves immune function and slows tumor growth. All participants receive the same treatment; there is no placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRaG-1 Cordycepin Tablets (a natural compound from Cordyceps fungus) combined with radiation therapy, GM-CSF injections, and PD-1/PD-L1 inhibitors
- What this could lead to
- If this works, it could offer a new treatment option for people with advanced solid tumors who have run out of standard options.
- What could go wrong
- This is a small, early-phase trial with only 65 participants and no comparison group, so results may not apply broadly. The combination therapy may cause side effects or fail to slow tumor growth.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed treatment-naïve or relapsed/metastatic advanced solid malignancies with no standard treatment option per current clinical guidelines or intolerance to standard therapy; measurable metastatic lesions ≥1 cm (by RECIST criteria); absolute lymphocyte count (ALC) below lower limit of normal (LLN). 3. No history of congestive heart failure, unstable angina, or unstable cardiac arrhythmias within the past 6 months. 4. ECOG performance status 0-3; estimated life expectancy ≥3 months. 5. No history of significant hematologic, cardiac, pulmonary, hepatic, or renal dysfunction. 6. Baseline AST ≤3×ULN and ALT ≤3×ULN (≤5×ULN for hepatocellular carcinoma or liver metastases); creatinine ≤3×ULN. 7. Capacity to comprehend study procedures and voluntarily provide written informed consent. Exclusion Criteria: 1. History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical carcinoma in situ. 2. Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that, in the investigator's judgment, may interfere with informed consent or treatment adherence. 3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, NYHA Class II or higher congestive heart failure, severe arrhythmias requiring pharmacological intervention, or myocardial infarction within the past 12 months. 4. History of solid organ transplant requiring ongoing immunosuppressive therapy. 5. Known significant active infection, or significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious uncontrolled comorbidities as determined by the investigator. 6. Allergy to any component of the study drug(s). 7. History of immunodeficiency, including HIV infection, acquired or congenital immunodeficiency disorders, solid organ transplant, or chronic immunosuppressive therapy for immune-related conditions. 8. Active or latent tuberculosis infection confirmed by positive T-SPOT.TB test or chest X-ray findings suggestive of tuberculosis. 9. Any other condition that, in the investigator's clinical judgment, may compromise study participation or safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Radiation plus targeted antibody tested in older head and neck cancer patients