RVU 120 (SEL120) to be tested in for treatment patients with solid tumors who have failed previous available standard therapy
- Conditions
- Relapsed / Refractory Metastatic or Advanced Solid TumorsMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005923-35-PL
- Lead Sponsor
- Ryvu Therapeutics S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 193
Inclusion criteria for Part 1 and Part 2:
1. Age 18 years or older
2. 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
3. At least one measurable or evaluable disease according to RECIST
v1.1 (Appendix 1)
4. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-
2 (Appendix 3)
5. Estimated life expectancy of at least 12 weeks
6. Toxicities incurred as a result of previous anti-cancer therapy resolved
to = Grade 1 (as defined by National Cancer Institute Common
Terminology Criteria for Adverse Events [NCI CTCAE] v5.0, Appendix 2),
except for alopecia, lymphopenia assessed as non-clinically significant,
sensory neurotoxicity and erectile dysfunction that could be = Grade 2
7. At least a 4-week interval between the last received radiotherapy and
the first scheduled day of dosing with RVU120 (with the exception of
palliation radiotherapy which is allowed up to 2 weeks prior the first
scheduled day of dosing)
8. Complete recovery from major surgery (stable and < Grade 2 toxicity
sequela acceptable)
9. At least 2 weeks beyond high dose systemic corticosteroids (however,
low dose corticosteroids < 20 mg prednisone or equivalent daily are
permitted)
10. Laboratory values at Screening and /or at Day 1 Cycle 1 pre-dose:
a. Absolute neutrophil count =1.5 x 109/L without colony stimulating
factor support
b. Platelets > 100 x 109/L
c. Only for Part 1: Hemoglobin =9 g/dL (or =2.2 mmol/L) without red
blood cell transfusion within 4 weeks
d. Serum albumin = 30g/L (3.0g/dL)
e. Total bilirubin <1.5 times the upper limit of normal (ULN)
f. Aspartate aminotransferase (AST ; SGOT) =3 x ULN; alanine
aminotransferase (ALT ;SGPT) =3 x ULN; (=5 x ULN for patients with advanced solid tumors with liver metastases); Alkaline phosphatase = 5
x ULN for patients with advanced solid tumors with bone or liver
metastases
g. Creatinine clearance =60 mL/min (Cockcroft-Gault formula Appendix
4)
h. Normal coagulation (elevated international normalized ratio [INR],
prothrombin time or activated partial thromboplastin time [APTT] <1.3 x
ULN acceptable)
11. Left ventricular ejection fraction> 50% by echocardiogram or
multiple gated acquisition (MUGA)
12. Able to provide an archival or fresh tumor biopsy sample at
Screening. For patients in Part 2, baseline tumor biopsy samples from
progressive disease lesions, where feasible, are required
13. 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 (see Appendix 5). Females must
also refrain from donating blood or egg (ovum) during the same timeperiod
14. 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
15. 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
16. Capable of understanding the mandated and optional protocol
requirements, is willing and able to c
General exclusion criteria for both Part 1 and Part 2:
Any of the following will exclude a patient from enrolment:
1. 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)
2. Prior history of, or planned organ or hematopoietic stem cell
transplant
3. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or
viral infection and acute inflammatory conditions (including pancreatitis)
4. Known HIV infection with a CD4+ T-cell (CD4+) count of < 350
cells/µL or a history of AIDS defining opportunistic infection within the
past 12 months or on established antiretroviral therapy for < 4 weeks or
presenting with a viral load of > 400 copies/mL prior to enrollment or on
antiretroviral therapy or prophylactic antimicrobials that are expected to
cause significant drug-drug interactions or overlapping toxicities with
study treatment and cannot be changed to alternative agents
5. Known positive test of / or known active diagnosis of COVID-19 viral
infection
6. Ongoing significant liver disease such as cirrhosis, drug-induced liver
injury, active hepatitis or chronic persistent hepatitis B and/or C
•Positive serologic or polymerase chain reaction (PCR) test results for
acute or chronic hepatitis B virus (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 hepatitis C virus (HCV) infection. Patients who are
positive for HCV antibody must be negative for HCV by PCR to be eligible
for study participation
7. Impairment of gastrointestinal function or gastrointestinal disease
that may significantly alter the absorption of RVU120 (e.g., active
inflammatory bowel disease, ulcerative disease, malabsorption
syndrome, short bowel syndrome, uncontrolled nausea, persistent
vomiting or diarrhea)
8. Ongoing drug-induced pneumonitis
9. Concurrent participation in another investigational clinical trial
10. 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 SOC 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 (Appendix 6)
11. Mean measurement QTcF of >470 msec on triplicate
electrocardiograms (ECGs) performed within 5 minutes of each other,
using QTcF (Fredericia) formula
12. 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 (Appendix 7)
(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)
13. Patients with clinicall
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method