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

NCT07681674 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BiCAP-201
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Solid Tumors

Keywords

Continued Access Protocol; Zelenectide pevedotin; Nuzefatide pevedotin; BT7480; Bicycle Drug Conjugate (BDC); Bicycle TICA; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Monitor safety for participants receiving a Bicycle investigational product

  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

  Up to 48 months

Study Arms (3)

Zelenectide pevedotin

EXPERIMENTAL

Drug: Zelenectide pevedotin

BT7480

EXPERIMENTAL

Drug: BT7480

Nuzefatide pevedotin

EXPERIMENTAL

Drug: Nuzefatide pevedotin

Interventions

Zelenectide pevedotin DRUG

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

Zelenectide pevedotin

BT7480 DRUG

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

BT7480

Nuzefatide pevedotin DRUG

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

Nuzefatide pevedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BicycleTx Limited: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share