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New cancer drug RS-0139 tested in humans for first time

NCT ID NCT04261413

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a new drug called RS-0139 in 16 people with advanced solid tumors that had stopped responding to standard treatments. The drug is designed to target tumors specifically, and the main goals were to find a safe dose and understand how the body processes it. Researchers also looked for signs of tumor shrinkage and changes in tumor markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RS-0139 (a tumor-targeted prodrug)
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early, small Phase 1 trial with only 16 participants, focused on safety and dosing. It is too soon to know if the drug will effectively shrink tumors or improve survival.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2026

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 to 75 years

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: * Patients who have consented to participation in the trial. * Patients of both sexes aged between 18 and 75 years. * Patients with relapsed or refractory solid tumors who have failed available standard therapy or are not candidates for standard therapy. * Patients who are willing to provide fresh or archival biopsy material before their participation to identify the integrin expression levels (for Phase Ib only). * Patients who completed the previous treatments 21 days before the first dose of the study drug. * Patients who have at least three months of life expectancy. * Patients with ECOG performance score 0 to 1. * Patients with adequate organ function defined as: * Hemoglobin ≥10 mg/dl * Neutrophil ≥1,500/µL * Platelet ≥100,000/µL * Creatinine ≤1.5xULN or creatinine clearance ≥60mL/sec/1.73m2 * Total bilirubin ≤ 1.5xULN * AST/ALT ≤2.5xULN; for patients who have confirmed liver metastasis: AST/ALT ≤5xULN. * Prothrombin time ≤1.5xULN (in case of no anticoagulant treatment). * Normal levels of serum magnesium and potassium concentrations Exclusion Criteria: * Patients with active and/or uncontrolled central nervous system (CNS) metastasis. * Patients who have interstitial lung disease or interstitial pneumonia. * Patients who have serious cardiac dysfunction. * Patients who have insufficient target organ function. * Patients with positive tests for HAV, HBV, HCV or HIV. * Patients who experienced grade 3 or higher toxicity related to the previous docetaxel treatment. * Female patients who are pregnant or breastfeeding. * Male patients with pregnant female partners. * Patients enrolled in another clinical trial at the same time or recently completed an investigational drug study and received the last dose of an investigational drug within 30 days or five half-lives (whichever is longer). * Patients who have serious medical conditions such as uncontrolled infection or untreated wounds. * Patients who have bone marrow transplantation history. * Patients who have hypersensitivity to docetaxel, components of RS-0139 and/or other taxanes. * Patients taking inhibitors or inducers of CYP3A4, including grapefruit juice and OTC medications such as St. John's Wort. * Patients who, in the judgment of the PI, are likely to be non-compliant or unable to cooperate. * Patients who cannot be contacted in case of emergency. * Patients who are the PI or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.

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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.

Contacts and locations

Locations

  • Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi

    Ankara, Turkey (Türkiye)

  • Koç University Hospital Phase I Center

    Istanbul, Turkey (Türkiye)

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