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BT7480

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Bicycle Therapeutics plc|Last Updated: Jan 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05163041Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 ExpressionPHASE1 ACTIVE NOT_RECRUITING 200 — — Nov 2, 2021Dec 1, 2026Jan 15, 20269 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Number of patients with treatment emergent adverse events in dose escalation phase
From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug

Incidence and severity of treatment emergent adverse events to assess safety and tolerability following treatment with BT7480 alone and in patients with renal insufficiency using NCI CTCAE v5.0 criteria

Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months

Overall response rate (ORR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria

Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months

Clinical benefit rate (CBR) following treatment with BT7480 alone and in combination with nivolumab according to RECIST 1.1 criteria nivolumab according to RECIST 1.1 criteria

Secondary Endpoints
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months
Number of patients with treatment emergent adverse events in dose expansion phase
From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BT7480 monotherapy dose escalationEXPERIMENTALParticipants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm.
BT7480 and nivolumab dose escalationEXPERIMENTALParticipants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients will participate in this dose escalation arm.
BT7480 monotherapy dose expansionEXPERIMENTALParticipants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
BT7480 and nivolumab dose expansionEXPERIMENTALParticipants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
BT7480 monotherapy in patients with renal insufficiencyEXPERIMENTALParticipants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm.
Interventions
NameTypeDescription
BT7480DRUGParticipants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle
NivolumabDRUGNivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator * Must have a histologically or cytologically confirmed malignant so...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05163041primaryCompletionDate: changed
LOWMay 24, 2026NCT05163041studyFirstPostDate: changed