Status:
NOT_YET_RECRUITING
RVU120 Rollover Study
Lead Sponsor:
Ryvu Therapeutics SA
Conditions:
Advanced Solid Tumors
Acute Myeloid Leukaemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the t...
Detailed Description
Participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdr...
Eligibility Criteria
Inclusion
- The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.
- The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.
- The participant does not have access to commercially available comparator anticancer therapy.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant signed the rollover study ICF prior to any study-related procedure or study data collection.
- The participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose.
- The investigator considers the participant to be eligible for participation in the rollover study.
Exclusion
- Presence of toxicity that cannot be adequately managed.
- Concurrent participation in any therapeutic clinical study other than the parent study.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06987058
Start Date
December 15 2025
End Date
August 1 2026
Last Update
September 24 2025
Active Locations (2)
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1
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
2
Clinica Universidad de Navarra
Pamplona, Spain, 31008