RVU120 Rollover Study

You may be able to join if

• 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.
• No access to commercially available alternative anticancer therapy or, if avaialable, not clinically appropriate.
• Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants: • A female participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: o Is of NCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR o Is of CBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year) and with low user dependency, as described in Appendix 4, during study intervention and until 28 weeks (~6.5 months) after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A participant of CBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations ≤3 days before the first dose of study intervention (Section 8.3.7). o If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.7. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity where pregnancy can occur to decrease the risk for inclusion of a participant with an early undetected pregnancy. Male participants: • A male participant is eligible to participate if they agree to all of the following during study intervention and until 28 weeks (~6.5 months) after the last dose: o Refrain from donating sperm. PLUS, either: o Be abstinent from intercourse where pregnancy may occur (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR o Must agree to use a barrier method as detailed below: Agree to use an external condom and should also be advised of the benefit for a CBP partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a CBP individual who is not currently pregnant. Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
• 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.