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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ryvu Therapeutics SA

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