RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors (NCT05052255) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors
Poland, Spain120 participantsStarted 2021-08-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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);
Exclusion criteria
✕. 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;
✕. 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);