RVU120 Rollover Study

Phase 2Enrolling By InvitationNCT06987058

Ryvu Therapeutics SA14 enrolled

Overview

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 time on treatment when continued under the same regimen as in the parent study. To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

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 withdrawal from the treatment or the study is met.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Acute Myeloid Leukaemia (AML)High-risk Myelodysplastic Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles. 2. 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. 3. The participant does not have access to commercially available comparator anticancer therapy. 4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection. 6. The participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose. 7. The investigator considers the participant to be eligible for participation in the rollover study. Exclusion Criteria: 1. Presence of toxicity that cannot be adequately managed. 2. Concurrent participation in any therapeutic clinical study other than the parent study.

Locations (7)

Hôpital l'Archet 1 - CHU de Nice; Service Hématologie Clinique

Nice, France

Hôpital Haut-Lévêque- CHU de Bordeaux, Centre François Magendie, Service d'Hématologie Clinique et Thérapie Cellulaire

Pessac, France

M2M Med Sp. Z o.o.

Chorzów, Poland

CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz

Gdansk, Poland

Pratia Hematologia Sp. z o.o. Pratia Onkologia Katowice

Katowice, Poland

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych

Wroclaw, Poland

Outcomes

Primary Outcomes

Incidence of Adverse Events (Safety and Tolerability)

Number and grade of adverse events assessed by CTCAE v5.0

Time frame: 12 months

Secondary Outcomes

Duration of response

Time from the first administration of RVU120-based treatment in the parent study until discontinuation of RVU120-based treatment for any reason in the rollover study.