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RVU120 (SEL120) in Patients With Relapse/Refractory Metastatic or Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05052255
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Ryvu Therapeutics SA

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: RVU120 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation / Part 2: Cohort Expansion

Part 1-Dose Escalation: Escalating doses of RVU120, in patients who have progressed from previous therapy.

Part 2-Cohort Expansion: Recommended dose in patients with tumor types selected from part 1.

Drug: RVU120
RVU120 will be administered as a single oral dose every other day for a total of 7 doses over a 3 week treatment cycle until disease progression or unacceptable toxicity.




Primary Outcome Measures :
  1. 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

  2. Dose Finding in part I [ Time Frame: Up to 2 years ]
    Determination of Recommended phase 2 dose assessing all available data

  3. 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)

  4. Duration of Response in part II [ Time Frame: Up to 2 years ]
    Duration of Response, as Assessed by RECIST v1.1

  5. Progression Free Survival in part II [ Time Frame: Up to 2 years ]
    Progression Free Survival as Assessed by RECIST v1.1

  6. 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


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 2 years ]
    Assessed of the maximum plasma concentration (Cmax)

  2. Minimum Plasma Concentration (Cmin) [ Time Frame: Up to 2 years ]
    Assessed of the minimum plasma concentration (Cmin)

  3. Time to Cmax [ Time Frame: Up to 2 years ]
    Assessed of the Time to Cmax (Tmax)

  4. Area Under the Curve [ Time Frame: Up to 2 years ]
    Assessed of the Area Under the Concentration Time-Curve (AUC) from Time Zero to Dosing Interval (AUC0-tau)

  5. Objective Overall Response [ Time Frame: Up to 2 years ]
    Objective Overall Response as Assessed by RECIST v1.1

  6. Duration of Response [ Time Frame: Up to 2 years ]
    Duration of Response, as Assessed by RECIST v1.1

  7. Progression Free Survival [ Time Frame: Up to 2 years ]
    Progression Free Survival as Assessed by RECIST v1.1

  8. Overall Survival [ Time Frame: Up to 2 years ]
    Assessment of Overall Survival from the date of first dose until the date of death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Signed informed consent prior to initiation of any study-specific procedures and treatment
  • Pathologically confirmed advanced solid tumor for which no standard therapy is available
  • Progressive disease, measurable according to RECIST v1.1
  • ECOG Performance Status 0-2
  • Adequate organ function based on laboratory values
  • Complete recovery from major surgery (stable and toxicity sequelae less than or equal to grade 2, as determined by NCI CTCAE v5.0
  • Able to provide an archival or fresh tumor biopsy sample at screening

Exclusion Criteria

  • Radiotherapy within 28 days prior to initiation of study treatment (except 14 days for palliative radiotherapy)
  • Anti-cancer medication or high-dose systemic corticosteroids prior to initiation of study treatment
  • Active brain metastases
  • Prior history of or planned organ or hematopoietic stem cell transplant
  • Ongoing uncontrolled systemic infection, acute inflammatory condition, significant liver disease, gastrointestinal disease, or clinically significant cardiovascular disease
  • Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to less then or equal to grade 1, as determined by CTCAE v5.0, except for alopecia, lymphopenia assessed as non-clinically significant, sensory neuropathy and erectile dysfunction that could be less than or equal to grade 2
  • Taking medications or supplements known to be strong inhibitors or strong inducers or sensitive substrates of CYP1A2
  • Taking medication that risk prolonged QTc or TdP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052255


Contacts
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Contact: Head of Clinical Operations +48 538 898 766 clinicaltrials@ryvu.com

Locations
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Poland
Medical University Early Phase 1 Research Center / Uniwersyteckie Centrum Kliniczne Ośrodek Badań Klinicznych Wczesnych Faz Recruiting
Gdańsk, Poland, 80-214
Contact: Rafał Dziadziuszko, MD    +48 58 584 45 71      
Principal Investigator: Rafał Dziadziuszko, MD         
Maria Sklodowska-Curie National Research Institute of Oncology / Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Recruiting
Warsaw, Poland, 02-781
Contact: Iwona Ługowska, MD    +48 22 546 33 81      
Principal Investigator: Iwona Ługowska, MD         
Sponsors and Collaborators
Ryvu Therapeutics SA
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Responsible Party: Ryvu Therapeutics SA
ClinicalTrials.gov Identifier: NCT05052255    
Other Study ID Numbers: RVU120-SOL-021
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryvu Therapeutics SA:
Relapse
Refractory
Metastatic
Advanced
Solid Tumor
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes