Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product

Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study

BiCAP-201 trial offers continued access to Bicycle investigational product treatments zelenectide pevedotin, nuzefatide pevedotin, and BT7480 for participants currently receiving and deriving clinical benefit from one of these treatments in a Bicycle Therapeutics-sponsored clinical trial. Bicycle Therapeutics will continue to monitor longer term safety of these treatments.

Inclusion Criteria:

• Participants must be receiving a Bicycle investigational product in another Bicycle-sponsored clinical study and will benefit from continued study treatment as assessed by the Investigator. The participant must be tolerating the treatment and the disease being treated has not grown on the treatment and have not met a treatment discontinuation criterion on the parent study.
• Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
• Pregnancy must be avoided while on treatment and for up to 6.5 months following end of study treatment.
• Participants must have completed testing requirements of the Bicycle-sponsored parent study.

Exclusion Criteria:

• Participant is receiving pembrolizumab or nivolumab only, and has been treated for >24 months from start of therapy on the parent study.
• Participant is receiving Bicycle investigational product post-disease progression.
• Participant has a new medical condition requiring treatment with strong cytochrome P450 3A (CYP3A) inhibitor or inducer while receiving zelenectide pevedotin or nuzefatide pevedotin.