Can a new IV drug shrink advanced solid tumors?

NCT ID NCT07797426

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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