Advanced Solid TumorPhase 1/2NCT05052255
RVU120 (SEL120) in Patients With Relapse/Refractory Metastatic or Advanced Solid Tumors
A Phase 1/2 study testing RVU120 in people with Advanced Solid Tumor, run by Ryvu Therapeutics SA at 7 sites in 2 countries.
Trial summary
This is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- RVU120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Aug 2021to 2 Oct 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Histologically confirmed and/or documented advanced or metastatic tumors who have exhausted the available standard treatment(s) of the respective country and/or progressing from at least one previous systemic therapy and not eligible to further available therapy;
- At least one measurable or evaluable disease according to RECIST v1.1;
- Performance status of ECOG 0-2;
- Estimated life expectancy of at least 12 weeks;
- Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤ Grade 1 (as defined by NCI CTCAE v5.0), except for alopecia, lymphopenia assessed as non-clinically significant, sensory neurotoxicity and erectile dysfunction that could be ≤ G2;
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- At least a 4-week interval between the last received radiotherapy and the first scheduled day of dosing with RVU120 (SEL120) (with the exception of palliation radiotherapy which is allowed up to 2 weeks prior the first scheduled day of dosing);
- Complete recovery from major surgery (stable and < Grade 2 toxicity sequela acceptable);
- At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted);
- Laboratory values at Screening and or at D1C1 pre-dose:
- Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support;
- Platelets 100 x 109/L;
- Only for Part 1: Hemoglobin ≥9 g/dL (or ≥2.2 mmol/L) without RBC transfusion within 4 weeks;
- Serum albumin ≥ 30g/L (3.0g/dL);
- Total bilirubin <1.5 times the upper limit of normal (ULN);
- AST (SGOT) ≤3 x ULN; ALT (SGPT) ≤3 x ULN; (≤5 x ULN for patients with advanced solid tumors with liver metastases); ALP ≤5 x ULN for patients with advanced solid tumors with bone or liver metastases
- Creatinine clearance ≥60 mL/min (Cockroft-Gault formula Appendix 4);
- Normal coagulation (elevated INR, prothrombin time or APTT <1.3 x ULN acceptable);
- Left ventricular ejection fraction> 50% by echocardiogram or MUGA;
- Able to provide an archival or fresh tumor biopsy sample at Screening. For patients in Part 2 of study, baseline tumor biopsy samples from progressive disease lesions, where feasible, are required;
- For women of childbearing potential (WOCBP), a negative pregnancy test must be confirmed before enrolment. WOCBP must commit to using highly effective contraception during study participation and until 6 months after the last dose of study drug. Females must also refrain from donating blood or egg (ovum) during the same time-period;
- For males, an effective barrier method of contraception must be used during study participation until 6 months after the last dose of study drug, if the patient is sexually active with a WOCBP. Males must also refrain from donating blood or sperm during the same time-period;
- Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice;
- Capable of understanding the mandated and optional protocol requirements, is willing and able to comply with the study protocol procedures and has signed the main informed document prior to any study specific procedure. For any optional biopsy sampling (tissue and/or blood) and long-term sample storage, additional consent is required;
- Patients must have been off anti-cancer treatment and prohibited concomitant medications, for 4 weeks or 5 half-lives, whichever is shorter;
- Specific Additional Inclusion Criteria for Part 2 (Group A1):
- Histologically or cytologically confirmed TNBC of the MSL subtype based on the most recent analyzed biopsy or other pathology specimen.
- Specific Additional Inclusion Criteria for Part 2 (Group A2):
- Histologically or cytologically confirmed TNBC other than the MSL subtype based on the most recent analyzed biopsy or other pathology specimen.
Who cannot join
- Active brain metastasis [patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial];
- Prior history of or planned organ or hematopoietic stem cell transplant;
- Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis);
- Known HIV infection with a CD4+ T-cell (CD4+) count of less than 350 cells/μL or a history of AIDS defining opportunistic infection within the past 12 months or on established antiretroviral therapy for less than 4 weeks or presenting with a viral load of more than 400 copies/mL prior to enrollment or on antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant DDIs or overlapping toxicities with study treatment and cannot be changed to alternative agents;
- Known positive test of / or known active diagnosis of COVID-19 viral infection.
- Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis or chronic persistent hepatitis B and/or C;
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- Positive serologic or PCR test results for acute or chronic HBV infection. Patients whose HBV infection status cannot be determined by serologic test results must be negative for HBV by PCR to be eligible for study participation. (www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf)
- Acute or chronic HCV infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 (SEL120) (e.g., active inflammatory bowel disease, ulcerative disease, malabsorption syndrome, short bowel syndrome, uncontrolled nausea, persistent vomiting or diarrhea);
- Ongoing drug-induced pneumonitis;
- Concurrent participation in another investigational clinical trial;
- Taking any medications, herbal supplements or other substances (including smoking) that are known to be strong inhibitors or strong inducers or sensitive substrates of CYP1A2; with the exception of antibiotics, antifungals, and antivirals that are used as the standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient and no suitable or available alternative could be found, with prior approval of the Sponsor Study Medical Director;
- Mean measurement QTcF of >470 msec on triplicate electrocardiograms (ECGs) performed within 5 minutes of each other, using QTcF (Fredericia) formulation;
- Currently taking drugs that are documented in the drug package insert, to have risk of causing prolonged QTc or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued). Please also consult the following Credible Meds web page: https://crediblemeds.org/index.php/login/dlcheck (antibiotics, antifungals, and antivirals that are used as standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient and no suitable or available alternative could be found, can be used with prior approval by Sponsor Study Medical Director)
- Patients with clinically significant cardiovascular disease. This includes: Myocardial infarction or unstable angina < 6 months prior to Screening; NYHA Grade III or greater congestive heart failure (Appendix 8); cerebrovascular accident including transient ischemic attack within the past 6 months; Uncontrolled hypertension; Serious or uncontrolled cardiac arrhythmia; Personal history of Torsade de Pointe or syndrome of congenital QTc prolongation or QTc > 470 msec.;
- Any other prior or current medical condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the Investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study;
- Pregnant or breast-feeding females;
- Specific Exclusion Criteria for Part 2, Group A1 and A2:
- Prior history of malignancies other than TNBC, unless the patient has been free of the disease for 5 years or more prior to Screening. Exceptions to the ≥5-year time limit include history of the following:
- basal cell carcinoma of the skin;
- non-metastatic squamous cell carcinoma of the skin;
- carcinoma in situ of the cervix;
- carcinoma in situ of the breast;
- carcinoma in situ of the bladder;
- incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b).
- More than 3 prior lines of systemic therapy for metastatic disease.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Poland4 sites
Beskidzkie Centrum Onkologii, Szpital Miejski im.
Bielsko-Biala
Medical University Early Phase 1 Research Center / Uniwersyteckie Centrum Kliniczne Ośrodek Badań Klinicznych Wczesnych Faz
Gdansk, 80-214
UCK im. prof. K. Gibińskiego
Katowice, 40-514
Maria Sklodowska-Curie National Research Institute of Oncology / Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, 02-781
Spain3 sites
Next Oncology Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Next Oncology Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
About this study
Official title: An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients With Relapse / Refractory Metastatic or Advanced Solid Tumors
This is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy.
Read the detailed description
The dose-escalation phase (Part 1) will be followed by an expansion phase (Part 2). Part 1 will evaluate the safety/tolerability and pharmacokinetics of increasing doses of RVU120 (SEL120) administered as a single dose every other day (7 doses in a 3 week cycle). Part 2 will collect additional data on safety, pharmacokinetics and efficacy at the recommended dose in patients with tumor types selected in Part 1.
- Conditions
- Advanced Solid Tumor
- Being tested
- RVU120
- Keywords
- Relapse, Refractory, Metastatic, Advanced, Solid Tumor
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVU120Drug
RVU120 will be administered as a single oral dose every other day over a 3 week treatment cycle until disease progression or unacceptable toxicity and an alternative daily dosing schedule will also be tested.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation / Part 2: Cohort Expansion | Experimental | Part 1-Dose Escalation: Escalating doses of RVU120, in patients who have progressed from previous therapy.
Part 2-Cohort Expansion and Alternative Schedule Investigation: Recommended dose in patients with tumor types selected from part 1 and escalation for alternative schedule. Receives: Drug: RVU120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events in part I
Evaluation of frequency and nature of adverse events, serious adverse events and dose limiting toxicities
Measured: Up to 2 years
Dose Finding in part I
Determination of Recommended phase 2 dose assessing all available data
Measured: Up to 2 years
Objective Overall Response in part II
Objective Overall Response as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Measured: Up to 2 years
Duration of Response in part II
Duration of Response, as Assessed by RECIST v1.1
Measured: Up to 2 years
Progression Free Survival in part II
Progression Free Survival as Assessed by RECIST v1.1
Measured: Up to 2 years
Overall Survival in part II
Assessment of Overall Survival from the date of first dose until the date of death from any cause
Measured: Up to 2 years
Secondary outcomes (8)
Maximum Plasma Concentration (Cmax)
Assessed of the maximum plasma concentration (Cmax)
Measured: Up to 2 years
Minimum Plasma Concentration (Cmin)
Assessed of the minimum plasma concentration (Cmin)
Measured: Up to 2 years
Time to Cmax
Assessed of the Time to Cmax (Tmax)
Measured: Up to 2 years
Area Under the Curve
Assessed of the Area Under the Concentration Time-Curve (AUC) from Time Zero to Dosing Interval (AUC0-tau)
Measured: Up to 2 years
Objective Overall Response
Objective Overall Response as Assessed by RECIST v1.1
Measured: Up to 2 years
Duration of Response
Duration of Response, as Assessed by RECIST v1.1
Measured: Up to 2 years
Progression Free Survival
Progression Free Survival as Assessed by RECIST v1.1
Measured: Up to 2 years
Overall Survival
Assessment of Overall Survival from the date of first dose until the date of death from any cause
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start13 Aug 2021
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryvu Therapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052255
- Sponsor's protocol ID
- RVU120-SOL-021
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients With Relapse / Refractory Metastatic or Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05052255
- Acronym / sponsor ID
- RVU120-SOL-021
- Conditions
- Advanced Solid Tumor
- Keywords
- Relapse, Refractory, Metastatic, Advanced, Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ryvu Therapeutics SAIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 22 Sep 2021 (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 is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy.
Detailed description
The dose-escalation phase (Part 1) will be followed by an expansion phase (Part 2). Part 1 will evaluate the safety/tolerability and pharmacokinetics of increasing doses of RVU120 (SEL120) administered as a single dose every other day (7 doses in a 3 week cycle). Part 2 will collect additional data on safety, pharmacokinetics and efficacy at the recommended dose in patients with tumor types selected in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation / Part 2: Cohort Expansion | Experimental | Drug: RVU120Part 1-Dose Escalation: Escalating doses of RVU120, in patients who have progressed from previous therapy. Part 2-Cohort Expansion and Alternative Schedule Investigation: Recommended dose in patients with tumor types selected from part 1 and escalation for alternative schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Age 18 years or older;
- Histologically confirmed and/or documented advanced or metastatic tumors who have exhausted the available standard treatment(s) of the respective country and/or progressing from at least one previous systemic therapy and not eligible to further available therapy;
- At least one measurable or evaluable disease according to RECIST v1.1;
- Performance status of ECOG 0-2;
- Estimated life expectancy of at least 12 weeks;
Key exclusion criteria (26 listed)
- Active brain metastasis [patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial];
- Prior history of or planned organ or hematopoietic stem cell transplant;
- Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis);
- Known HIV infection with a CD4+ T-cell (CD4+) count of less than 350 cells/μL or a history of AIDS defining opportunistic infection within the past 12 months or on established antiretroviral therapy for less than 4 weeks or presenting with a viral load of more than 400 copies/mL prior to enrollment or on antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant DDIs or overlapping toxicities with study treatment and cannot be changed to alternative agents;
- Known positive test of / or known active diagnosis of COVID-19 viral infection.
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 |
|---|---|---|
| RVU120RVU120 will be administered as a single oral dose every other day over a 3 week treatment cycle until disease progression or unacceptable toxicity and an alternative daily dosing schedule will also be tested. | Drug | Part 1: Dose Escalation / Part 2: Cohort Expansion |
Primary outcome
Adverse events in part I
Time frame: Up to 2 years
Evaluation of frequency and nature of adverse events, serious adverse events and dose limiting toxicities
Dose Finding in part I
Time frame: Up to 2 years
Determination of Recommended phase 2 dose assessing all available data
Objective Overall Response in part II
Time frame: Up to 2 years
Objective Overall Response as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Duration of Response in part II
Time frame: Up to 2 years
Duration of Response, as Assessed by RECIST v1.1
Progression Free Survival in part II
Time frame: Up to 2 years
Progression Free Survival as Assessed by RECIST v1.1
Overall Survival in part II
Time frame: Up to 2 years
Assessment of Overall Survival from the date of first dose until the date of death from any cause
8 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Up to 2 years
Minimum Plasma Concentration (Cmin)
Time frame: Up to 2 years
Time to Cmax
Time frame: Up to 2 years
Area Under the Curve
Time frame: Up to 2 years
Objective Overall Response
Time frame: Up to 2 years
Duration of Response
Time frame: Up to 2 years
Progression Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RVU120 in people with Advanced Solid Tumor, run by Ryvu Therapeutics SA at 7 sites in 2 countries.
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 29 inclusion and 26 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: stopped early, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Adverse events in part I (time frame: Up to 2 years). The study lists 6 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 18 Sep 2026.