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BT8009

Phase 1

Urinary Bladder Neoplasm | Small molecule | Oncology |Bicycle Therapeutics plc|Last Updated: Nov 14, 2025

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 Enrollment329
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04561362Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced MalignanciesPHASE1 ACTIVE NOT_RECRUITING 329 — — Jul 17, 2020Dec 1, 2026Nov 14, 202524 United States, Canada +4
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Study Endpoints
Primary Endpoints
Parts A-1, A-2 and C: Number of participants with treatment emergent adverse events, receiving BT8009 as a monotherapy or in combination with pembrolizumab to assess safety and tolerability.
From cycle 1 day 1 until 30 days after the end of treatment or approximately 1 year

Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.

Parts A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 as a monotherapy or in combination with pembrolizumab
28 days (for cycles that are either 21 or 28 days in length depending on dosing schedule assigned)

Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy or in combination with pembrolizumab.

Part B1-B7: Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab using RECIST 1.1.
Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years

Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy or in combination with pembrolizumab according to RECIST 1.1 criteria.

Part D: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
From Cycle 1 Day 1 through end of treatment or for up to 1 year

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.

Part D: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
From Cycle 1 Day 1 through end of treatment or for up to 1 year

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone

Part D: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
From Cycle 1 Day 1 through end of treatment or for up to 1 year

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.

Part D: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
From Cycle 1 Day 1 through end of treatment or for up to 1 year

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.

PartsB-8, B-9: Number of participants with treatment emergent adverse events receiving an alternative dosing regimen of BT8009 monotherapy to assess safety and tolerability.
From cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 days)

Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving an alternative dose regimen of BT8009 as a monotherapy who experience treatment-emergent adverse events using CTCAE v5.0 criteria.

Secondary Endpoints
Parts B-1-B-7: Number of participants with treatment emergent adverse events receiving BT8009 as a monotherapy or in combination with pembrolizumab to assess safety and tolerability.
From cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule)
Part B: Duration of Response time to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab
Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years
Part B: Clinical benefit rate to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab
Every 8 weeks Parts A-1, A-2, and C) and every 9 weeks (cohorts B-8 and B-9) for 12 months then every 12 weeks thereafter until disease progression or death or up to 3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A-1 -BT8009 Monotherapy Dose EscalationEXPERIMENTALParticipants will receive escalating doses of BT8009.
Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-EscalationEXPERIMENTALParticipants will receive BT8009 and a standard dose of pembrolizumab.
Cohort B-1 - BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Cohort B-2- BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Cohort B-3- BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009. .
Cohort B-4- BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Cohort B-5- BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Cohort B-6- BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Cohort B-7- BT8009 in Combination with Pembrolizumab Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009 and standard dose of pembrolizumab.
Part C - Renal Insufficiency BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Part D - BT8009 Monotherapy Supplementary PKEXPERIMENTALParticipants will receive a selected dose of BT8009.
Part B-8 - BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Part B-9 - BT8009 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive a selected dose of BT8009.
Interventions
NameTypeDescription
BT8009DRUGBicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.
PembrolizumabDRUGParticipants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Key Inclusion Criteria * Life expectancy ≥12 weeks. * Patients must have measurable disease per RECIST 1.1. * Part A-1 cohorts: * Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate * Patie...

Countries:United StatesCanadaFranceItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04561362primaryCompletionDate: changed
LOWMay 24, 2026NCT04561362studyFirstPostDate: changed