Can a new IV drug shrink advanced solid tumors?
NCT ID NCT07797426
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called RT023, given by infusion, in adults with advanced solid tumors that have not responded to standard treatments. The study has two main goals: first, to find the safest dose and check for side effects, and second, to see whether RT023 can shrink tumors or slow their growth. Researchers will also measure how the drug moves through the body and whether the immune system reacts to it. The results will help decide if RT023 deserves further testing as a potential cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RT023, an experimental drug given by intravenous infusion
- What this could lead to
- If RT023 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work as hoped or may cause unexpected side effects. The results will only show preliminary signs of effectiveness, not a proven cure.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 318 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. Male or female participants aged 18 years or older at the time of signing the informed consent form (ICF); 2. Participants with histologically or cytologically confirmed advanced malignant solid tumors; 3. Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Participants with an expected survival ≥ 12 weeks; 5. Participants must have at least one measurable lesion based on RECIST v1.1; In dose escalation phase, participants without measurable lesions are permitted. Exclusion Criteria: 1. Participants with active central nervous system (CNS) metastases are excluded. However, participants are eligible if they have previously received radiotherapy or surgery, and imaging within 4 weeks prior to the first dose shows stable brain metastases without progression or new neurological symptoms, and corticosteroids have been withheld for at least 2 weeks prior to first dose. Participants with leptomeningeal or brainstem metastasis are not eligible regardless of treatment status; 2. Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated intervention; 3. Participants with poorly controlled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy; 4. Participants with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requiring corticosteroid therapy (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, etc.), or participants with current ILD/non-infectious pneumonitis; 5. Participants with clinically significant intercurrent lung-specific illnesses, including but not limited to any underlying pulmonary diseases diagnosed within 3 months prior to the first dose (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, etc.), any autoimmune, connective tissue, inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy; 6. Participants with a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Participants with any other conditions that may lead to premature discontinuation from the study, such as severe physical or psychiatric illness or laboratory abnormalities, which may increase the risk of study participation, affect treatment compliance, or interfere with the interpretation of study results, and who are deemed unsuitable for enrollment by the investigator.
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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.
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