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NCT Number: NCT07681674

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zelenectide pevedotin

Drug

Participants will continue on the same treatment regimen they were receiving in their parent study.

BT7480

Drug

Participants will continue on the same treatment regimen they were receiving in their parent study.

Nuzefatide pevedotin

Drug

Participants will continue on the same treatment regimen they were receiving in their parent study.

Primary outcomes

  1. Monitor safety for participants receiving a Bicycle investigational product

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BicycleTx Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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