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

NCT05052255 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: RVU120-SOL-021
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 7

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.

Conditions

Advanced Solid Tumor

Keywords

Relapse; Refractory; Metastatic; Advanced; Solid Tumor

Outcome Measures

Primary Outcomes (6)

• Adverse events in part I

  Evaluation of frequency and nature of adverse events, serious adverse events and dose limiting toxicities

  Up to 2 years

• Dose Finding in part I

  Determination of Recommended phase 2 dose assessing all available data

  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)

  Up to 2 years

• Duration of Response in part II

  Duration of Response, as Assessed by RECIST v1.1

  Up to 2 years

• Progression Free Survival in part II

  Progression Free Survival as Assessed by RECIST v1.1

  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

  Up to 2 years

Secondary Outcomes (8)

• Maximum Plasma Concentration (Cmax)

  Up to 2 years

• Minimum Plasma Concentration (Cmin)

  Up to 2 years

• Time to Cmax

  Up to 2 years

• Area Under the Curve

  Up to 2 years

• Objective Overall Response

  Up to 2 years

Study Arms (1)

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.

Drug: RVU120

Interventions

RVU120 DRUG

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.

Part 1: Dose Escalation / Part 2: Cohort Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);

You may not qualify if:

• 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;
• 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.;

Sponsors & Collaborators

• Ryvu Therapeutics SA: lead

Study Sites (7)

Beskidzkie Centrum Onkologii, Szpital Miejski im.

Bielsko-Biala, Poland

Location

Medical University Early Phase 1 Research Center / Uniwersyteckie Centrum Kliniczne Ośrodek Badań Klinicznych Wczesnych Faz

Gdansk, 80-214, Poland

Location

UCK im. prof. K. Gibińskiego

Katowice, 40-514, Poland

Location

Maria Sklodowska-Curie National Research Institute of Oncology / Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Next Oncology Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Next Oncology Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 22, 2021
• Study Start: August 13, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); ES (3)