Advanced Solid TumorsPhase 2NCT07681674
Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product
A Phase 2 study testing Zelenectide pevedotin, BT7480 and Nuzefatide pevedotin in people with Advanced Solid Tumors, run by BicycleTx Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Zelenectide pevedotin, BT7480 and Nuzefatide pevedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study
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
- Being tested
- Zelenectide pevedotin, BT7480, Nuzefatide pevedotin
- Keywords
- Continued Access Protocol, Zelenectide pevedotin, Nuzefatide pevedotin, BT7480, Bicycle Drug Conjugate (BDC), Bicycle TICA, Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zelenectide pevedotinDrug
Participants will continue on the same treatment regimen they were receiving in their parent study.
BT7480Drug
Participants will continue on the same treatment regimen they were receiving in their parent study.
Nuzefatide pevedotinDrug
Participants will continue on the same treatment regimen they were receiving in their parent study.
| Study group | Role | What they receive |
|---|---|---|
| Zelenectide pevedotin | Experimental | Not described Receives: Drug: Zelenectide pevedotin |
| BT7480 | Experimental | Not described Receives: Drug: BT7480 |
| Nuzefatide pevedotin | Experimental | Not described Receives: Drug: Nuzefatide pevedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BicycleTx Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681674
- Sponsor's protocol ID
- BiCAP-201
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study
- ClinicalTrials.gov ID
- NCT07681674
- Acronym / sponsor ID
- BiCAP-201
- Conditions
- Advanced Solid Tumors
- Keywords
- Continued Access Protocol, Zelenectide pevedotin, Nuzefatide pevedotin, BT7480, Bicycle Drug Conjugate (BDC), Bicycle TICA, Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- BicycleTx LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zelenectide pevedotin | Experimental | Drug: Zelenectide pevedotin |
| BT7480 | Experimental | Drug: BT7480 |
| Nuzefatide pevedotin | Experimental | Drug: Nuzefatide pevedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zelenectide pevedotinParticipants will continue on the same treatment regimen they were receiving in their parent study. | Drug | Zelenectide pevedotin |
| BT7480Participants will continue on the same treatment regimen they were receiving in their parent study. | Drug | BT7480 |
| Nuzefatide pevedotinParticipants will continue on the same treatment regimen they were receiving in their parent study. | Drug | Nuzefatide pevedotin |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zelenectide pevedotin, BT7480 and Nuzefatide pevedotin in people with Advanced Solid Tumors, run by BicycleTx Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitor safety for participants receiving a Bicycle investigational product (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.