Solid TumorsPhase 1NCT04261413
Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing RS-0139 in people with Solid Tumors, run by RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. at 2 sites in Turkey (Türkiye).
Trial summary
This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RS-0139
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Dec 2021to 4 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara
Koç University Hospital Phase I Center
Istanbul
About this study
Official title: A Multicenter, Open Label, Two-step, Phase Ia/Ib Study of Tumor Targeted Prodrug RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Solid Tumors
This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.
- Conditions
- Solid Tumors
- Being tested
- RS-0139
- Keywords
- solid tumors, chemotherapy, targeted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-0139Drug
RS-0139 will be administered for the indication of solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| RS-0139 | Experimental | There will be only RS-0139 arm in the study. Receives: Drug: RS-0139 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: At the end of each cycle (Each cycle is 21 days)
The incidence of AEs, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Measured: At the end of each cycle (Each cycle is 21 days)
Secondary outcomes (14)
Anti-tumor activity measured by tumor shrinkage (based on CT-scan evaluations)
Measured: At the end of Phase Ib (assessed up to 1 year)
Change in CA 125 / CA15-3 / CA 19-9 / CA 72-4 (depends on the tumor type)
Measured: At the end of Phase Ib (assessed up to 1 year)
Change in circulating tumor cells
Measured: At the end of Phase Ib (assessed up to 1 year)
Objective Response Rate (ORR)
Measured: At the end of Phase Ib (assessed up to 1 year)
Progression-Free Survival (PFS)
Measured: At the end of Phase Ib (assessed up to 1 year)
Duration of Response (DoR)
Measured: At the end of Phase Ib (assessed up to 1 year)
Peak plasma concentration (Cmax)
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
AUC(o-t)
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
AUC(0-∞)
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
tmax
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
t1/2
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
λz
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
CL
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
Vss
Measured: At the end of the Phase Ia and Ib (assessed up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start13 Dec 2021
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261413
- Sponsor's protocol ID
- RS-001
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Two-step, Phase Ia/Ib Study of Tumor Targeted Prodrug RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04261413
- Acronym / sponsor ID
- RS-001
- Conditions
- Solid Tumors
- Keywords
- solid tumors, chemotherapy, targeted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RS-0139 | Experimental | Drug: RS-0139There will be only RS-0139 arm in the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-0139RS-0139 will be administered for the indication of solid tumors. | Drug | RS-0139 |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: At the end of each cycle (Each cycle is 21 days)
The incidence of AEs, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Time frame: At the end of each cycle (Each cycle is 21 days)
14 secondary outcomes
Anti-tumor activity measured by tumor shrinkage (based on CT-scan evaluations)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Change in CA 125 / CA15-3 / CA 19-9 / CA 72-4 (depends on the tumor type)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Change in circulating tumor cells
Time frame: At the end of Phase Ib (assessed up to 1 year)
Objective Response Rate (ORR)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Progression-Free Survival (PFS)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Duration of Response (DoR)
Time frame: At the end of Phase Ib (assessed up to 1 year)
Peak plasma concentration (Cmax)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
AUC(o-t)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
AUC(0-∞)
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
tmax
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
t1/2
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
λz
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
CL
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
Vss
Time frame: At the end of the Phase Ia and Ib (assessed up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RS-0139 in people with Solid Tumors, run by RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S. at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) (time frame: At the end of each cycle (Each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.