Advanced Solid Tumors
Conditions
Keywords
Continued Access Protocol, Zelenectide pevedotin, Nuzefatide pevedotin, BT7480, Bicycle Drug Conjugate (BDC), Bicycle TICA, Advanced Solid Tumors
Brief summary
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.
Interventions
Participants will continue on the same treatment regimen they were receiving in their parent study.
DRUGBT7480
Participants will continue on the same treatment regimen they were receiving in their parent study.
DRUGNuzefatide pevedotin
Participants will continue on the same treatment regimen they were receiving in their parent study.
Sponsors
BicycleTx Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitor safety for participants receiving a Bicycle investigational product | Up to 48 months | Incidence, severity, seriousness, relationship, and type of serious adverse events (SAEs), treatment-related adverse events (TRAEs), adverse events of clinical interest (AECIs), and treatment modifications as a result of any of these |
Outcome results
None listed