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Not yet recruiting NCT07681674

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

Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zelenectide pevedotin, BT7480, Nuzefatide pevedotin.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Zelenectide pevedotin
    Participants will continue on the same treatment regimen they were receiving in their parent study.
  • Drug BT7480
    Participants will continue on the same treatment regimen they were receiving in their parent study.
  • Drug Nuzefatide pevedotin
    Participants will continue on the same treatment regimen they were receiving in their parent study.

Primary outcome measures

  • Monitor safety for participants receiving a Bicycle investigational product [Time frame: Up to 48 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07681674 · BiCAP-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗