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

Sponsor
BicycleTx Limited
Study ID
NCT07681674
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
May 30, 2030
Completion
May 30, 2030

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zelenectide pevedotin
  • Experimental: BT7480
  • Experimental: Nuzefatide pevedotin

Primary Outcome Measure

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

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