Trial Title:
Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
NCT ID:
NCT06268574
Condition:
Acute Myeloid Leukemia (AML)
High-risk Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RVU120
Description:
RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
Arm group label:
RVU120 single agent
Other name:
SEL120
Summary:
The goal of this study is to assess the safety, tolerability, anti-tumor activity
(efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when
administered to adult patients with relapsed or refractory acute myeloid leukemia (AML)
or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no
alternative therapies available. The study consists of two parts. Part 1 will assess the
safety and tolerability of the dosages given and the level of anti-tumor activity or
clinical response. Based on the results from part 1 the study will continue to enrol
patient into Part 2 which will continue to evaluate safety and tolerability and
anti-tumor activity in a larger number of patients.
Detailed description:
Patients entering the study will undergo a Screening Period of up to 21 days, a Treatment
Period where they will take the drug every other day (7 times in 13 days) in cycles of 21
days, an End of Treatment period (lasting approximately 30 days after last dose), and a
1-year Follow-up Period where participants will be contacted every 3 months for
progression and survival status. In Part 1, patients with AML or HR-MDS will be enrolled.
All patients will receive RVU120 until the patient meets eligibility for transplant,
until there is disease progression or if there are signs of intolerance. A patient may
withdraw from the study at any time at their own request or may be withdrawn at any time
at the discretion of the Investigator. Depending on the outcome of part 1, part 2 may
include patients with HR-MDS and AML irrespective of NPM1 mutation status.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects must sign a written informed consent document and complete study related
procedures
- Patients must have a diagnosis of AML or HR-MDS (per 2022 WHO classification) with
MDS confirmed as high risk with IPSS-R
- Patients must have relapsed or refractory AML (per ELN 2022 criteria)
- Patients must have relapsed or progressing HR-MDS (per IWG response criteria)
- Patients must have failed first-line treatment and have no alternative therapeutic
options likely to produce clinical benefit
- Patients must have ECOG performance status of 0 to 2
- Patients must have adequate end organ function defined as:
1. WBC < 30 x 10(9)/L on Day 1 prior to first dose of study drug
2. Platelet count > 10,000/mcL on Day 1 prior to first dose of study drug
3. Serum albumin ≥ 25 g/L (2.5 g/dL)
4. Normal coagulation (elevated international normalized ratio [INR], prothrombin
time or activated partial thromboplastin time [APTT] <1.3 x the upper limit of
normal [ULN] acceptable)
5. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper
limit of normal)
6. Total bilirubin ≤ 3 x ULN
7. Creatinine clearance (Cockcroft & Gault formula) ≥ 30 mL/min
Exclusion Criteria:
- Active central nervous system (CNS) leukemia.
- Diagnosis of acute promyelocytic leukemia (APL), the M3 subtype of AML.
- Previous treatment with CDK8 and/or CDK19-targeted therapy.
- Major surgery within 28 days prior to first dose of study drug.
- Hematopoietic stem cell transplant within 120 days prior to first dose of study
drug.
- Active, ≥Grade 2 acute graft versus host disease (GVHD), active moderate-to-severe
chronic GVHD, or requirement for systemic immunosuppressive medications for GVHD
- Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection
and acute inflammatory conditions (including pancreatitis).
- Known seropositivity or history of active viral infection with human
immunodeficiency virus (HIV).
- Ongoing significant liver disease
- Impairment of gastrointestinal function or gastrointestinal disease
- Ongoing drug-induced pneumonitis.
- Concurrent participation in another investigational clinical trial.
- Taking any medications, herbal supplements, or other substances (including smoking)
that may interfere with the metabolism of the study drug
- Significant cardiac dysfunction defined as myocardial infarction within 12 months of
first dose of study drug, New York Heart Association (NYHA) Class III or IV heart
failure, uncontrolled dysrhythmias, poorly controlled angina or left ventricular
ejection fraction (LVEF) <40% as per echocardiography or multiple gated acquisition
(MUGA) scan.
- History of ventricular arrhythmia, or QTc ≥470 ms (Bazett's formula).
- Prior history of malignancies other than AML, unless the participant has been free
of the disease for 5 years or more prior to Screening
- Pregnant or breast-feeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
L'Hotel Dieu de Quebec
Address:
City:
Calgary
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Christophe Lemieux, Dr
Facility:
Name:
University of Alberta - Faculty of Medicine & Dentistry
Address:
City:
Vancouver
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
David Sanford, Dr
Facility:
Name:
Centre Hospitalier Universitaire Grenoble Alpes
Address:
City:
la Tronche
Country:
France
Status:
Recruiting
Contact:
Last name:
Coude-Eric Bulabois, Dr
Facility:
Name:
Centre Hospitalier Le Mans
Address:
City:
le Mans
Country:
France
Status:
Recruiting
Contact:
Last name:
Kamel Laribi, Dr
Facility:
Name:
Centre Hospitalier Universitaire de Lille (CHU Lille)
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laure Goursaud, Dr
Facility:
Name:
Institut Paoli Calmettes (IPC)
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sylvian Garciaz, Dr
Facility:
Name:
Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thomas Cluzeau, Dr
Facility:
Name:
Centre Hospitalier Universitaire de Nimes (CHU) - Institut de Cancerologie du Gard
Address:
City:
Nimes
Country:
France
Status:
Recruiting
Contact:
Last name:
Stefan Wickenhauser, Dr
Facility:
Name:
Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre Fenaux, Dr
Facility:
Name:
UNICANCER - Centre Henri-Becquerel
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Contact:
Last name:
Emilie Lamasle-Hue, Dr
Facility:
Name:
Azienda Ospedaliero Universitaria Delle Marche
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Debora Capelli, Dr
Facility:
Name:
Univerisity of Bologna Policlinico Sant'Orsola
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cristina Papayannidis, Prof.
Facility:
Name:
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Erika Borlenghi, Dr
Facility:
Name:
Careggi University Hospital
Address:
City:
Florence
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Valeria Santini, Prof.
Facility:
Name:
Ospedale Vito Fazzi Lecce
Address:
City:
Lecce
Zip:
73100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Nicola Di Renzo, Dr
Facility:
Name:
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Benedetta Giannini, Dr
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milan
Zip:
20162
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberto Cairoli, Dr
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sara Galimberti, Dr
Facility:
Name:
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Address:
City:
Roma
Zip:
00133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Adriano Venditti, Prof.
Facility:
Name:
Humanitas Mirasole S.p.A.
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Matteo Giovanni Della Porta, Prof.
Facility:
Name:
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ernesta Audisio, Dr
Facility:
Name:
MTZ Clinical Research
Address:
City:
Warszawa
Zip:
02-172
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Krzysztof Mądry
Phone:
+48 22 572 59 59
Email:
info@pratia.com
Contact backup:
Last name:
Krzysztof Mądry, MD
Facility:
Name:
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Address:
City:
Biala Podlaska
Zip:
21-500
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Piotr Centkowski, Dr
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Witold Prejzner, Dr
Facility:
Name:
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Małgorzata Krawczyk-Kuliś, Prof.
Facility:
Name:
Pratia Hematologia Sp. z o.o.
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Sebastian Grosicki, Prof.
Facility:
Name:
Szpital Wojewodzki Im. Dr. Ludwika Rydygiera w Suwalkach
Address:
City:
Suwałki
Zip:
16-400
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Alina Urbanowicz, Dr
Facility:
Name:
MICS Centrum Medyczne Toruń
Address:
City:
Toruń
Zip:
87-100
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Dominik Chraniuk
Phone:
+48 56 300 43
Email:
d.chraniuk@naszlekarz.pl
Contact backup:
Last name:
Dominik Chraniuk, MD
Facility:
Name:
Instytut Hematologii I Transfuzjologii
Address:
City:
Warsaw
Zip:
02-776
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Ewa Lech-Marańda, Prof.
Facility:
Name:
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Address:
City:
Warsaw
Zip:
04-141
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Krzysztof Gawroński, Dr
Facility:
Name:
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Address:
City:
Wałbrzych
Zip:
58-309
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Aleksandra Butrym, Prof.
Facility:
Name:
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
Address:
City:
Wrocław
Zip:
53-439
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Jarosław Dybko, Dr
Facility:
Name:
Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.
Address:
City:
Zielona Góra
Zip:
65-046
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Emilian Snarski, Prof.
Facility:
Name:
Hospital de la Santa Creu i de Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Guadalupe Onate, Dr
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sara Garcia Avila, Dr
Facility:
Name:
Institut Catala d'Oncologia Hospitalet
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Montserat Arnan Sangerman, Dr
Facility:
Name:
Complejo Hospitalario De Caceres - Hospital General San Pedro De Alcantara
Address:
City:
L'Hospitalet de Llobrega
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Juan Miguel Bergua Buergues, Dr
Facility:
Name:
Hospital Universitario La Paz (HULP)
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Irene Sanchez Vadillo, Dr
Facility:
Name:
MD Anderson Cancer Center Madrid
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Adolfo De La Fuente, Dr
Facility:
Name:
Hospital Regional Universitario de Málaga
Address:
City:
Malaga
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alejandro Contento Gonzalo, Dr
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Navarra
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ana Alfonso Pierola, Dr
Facility:
Name:
Virgen del Rocío University Hospital
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jose Antonio Perez Simon, Dr
Facility:
Name:
Hospital Universitario La Fe
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pau Montesinos Fernandez, Dr
Start date:
January 23, 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Ryvu Therapeutics SA
Agency class:
Industry
Source:
Ryvu Therapeutics SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06268574
