Urinary Bladder NeoplasmPhase 1/2NCT04561362
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
A Phase 1/2 study testing BT8009 and Pembrolizumab in people with Urinary Bladder Neoplasm and Triple Negative Breast Neoplasms, run by BicycleTx Limited at 24 sites in 6 countries.
Trial summary
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms
- What is being tested?
- BT8009 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 17 Jul 2020to Jan 2027
- Phase
- Phase 1/2
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
- 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
- Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample must be submitted); or
- Patients with advanced, histologically confirmed pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumors that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing for Nectin-4 expression).
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- Part A-2:
- Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
- Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that have progressed following prior therapy
- Cohort B-1: Histologically documented urothelial carcinoma, previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
- Cohort B-2 and B-3: Histologically documented urothelial carcinoma, not previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
- Cohort B-4: Patients with histologically confirmed non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria that have progressed following prior therapy.
- Cohort B-5: Patients with triple-negative breast cancer confirmed negative for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) (i.e., triple-negative) that have progressed following prior therapy.
- Cohort B-6: Patients with histologically confirmed non-small cell lung cancer (NSCLC) with no actionable mutations, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that have progressed following prior therapy.
- Cohort B-7: Locally advanced or metastatic, histologically confirmed urothelial (transitional cell) carcinoma, ineligible for cisplatin, no prior systemic anticancer treatment for advanced urothelial carcinoma.
- Cohort B-8: Locally advanced (unresectable) or metastatic, histologically confirmed breast cancer, either TNBC or hormone receptor (HR) positive and HER-2 negative according to ASCO/CAP guidelines and up to 3 prior lines of therapy for advanced (unresectable) or metastatic disease.
- Cohort B-9: Histologically confirmed advanced/metastatic squamous or non-squamous NSCLC, negative for oncogenic driver mutations (EGFR, KRAS, ALK, BRAF, MET, ERRB2).
- Cohort C renal insufficiency cohort: Patients with histologically documented urothelial carcinoma, ovarian, triple negative breast, or non-small cell lung cancer that have been previously treated with a locally approved therapy.
- Part D supplementary PK: Patients must have histologically confirmed urothelial (transitional cell) carcinoma (patients with squamous differentiation or mixed cell types are eligible); ovarian; triple-negative breast; or non-small cell lung cancer that have been previously treated with a locally approved therapy.
Who cannot join
- Clinically relevant troponin elevation
- Uncontrolled diabetes
- Known active or untreated CNS and/or carcinomatous meningitis
- Grade ≥2 peripheral neuropathy
- Active keratitis or corneal ulcerations
- Patients with uncontrolled hypertension
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- History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions).
- Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009.
- Prior Stevens-Johnson syndrome/toxic epidermal necrolysis on any MMAE-conjugated drug
- Parts A-2 and B-7 Pembrolizumab Combination Cohorts:
- Prior organ transplant (including allogeneic)
- Diagnosis of clinically relevant immunodeficiency
- History of interstitial lung disease
- Parts B-2 and B-3: Prior treatment with enfortumab vedotin Other protocol-defined Inclusion/Exclusion criteria may apply
- Parts B-8 and B-9: Prior treatment with an ADC containing an MMAE (vedotin) payload.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
United States9 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Ocala Oncology Center
Ocala, Florida, 34474
Advent Health
Orlando, Florida, 34747
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
France5 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69373
Institut Paoli-Calmettes
Marseille, 13009
Centre Eugene Marquis
Rennes, 35042
Institut Gustave Roussy
Villejuif, 94805
Spain5 sites
Vall d'Hebron Institute of Oncology
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
START Madrid Fundacion Jimenez Diaz
Madrid, 28040
Next Oncology - Hospital Quironsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitario Marques de Valdecilla
Santander, 39008
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133
Ospedale San Raffaele
Milan, 20132
United Kingdom2 sites
Sarah Cannon Research Institute UK
London, W1G 6AD
The Christie NHS Foundation Trust
Manchester, M20 4BX
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G IZ5
About this study
Official title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).
Read the detailed description
This study will assess the safety and tolerability of BT8009 alone and in combination with pembrolizumab in patients with select advanced solid tumors. BT8009 will be given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) or dosing on day 1 and day 8 of a 3-weekly (21 day cycle) and in combination with pembrolizumab. There are four parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, Part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Additionally Parts B-8 and B-9 will evaluate the safety and tolerability of an alternate dose and schedule of BT8009 monotherapy. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency. Part D will further characterize the pharmacokinetics of BT8009 and MMAE.
- Conditions
- Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Neoplasms
- Being tested
- BT8009, Pembrolizumab
- Keywords
- Nectin-4, Solid tumor, Transitional urothelial carcinoma, Renal insufficiency
- Medical subject headings
- Urinary Bladder Neoplasms, Triple Negative Breast Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT8009Drug
Bicyclic 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.
PembrolizumabDrug
Also called Keytruda
Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Part A-1 -BT8009 Monotherapy Dose Escalation | Experimental | Participants will receive escalating doses of BT8009. Receives: Drug: BT8009 |
| Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation | Experimental | Participants will receive BT8009 and a standard dose of pembrolizumab. Receives: Drug: BT8009; Drug: Pembrolizumab |
| Cohort B-1 - BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Cohort B-2- BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Cohort B-3- BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. . Receives: Drug: BT8009 |
| Cohort B-4- BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Cohort B-5- BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Cohort B-6- BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion | Experimental | Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab. Receives: Drug: BT8009; Drug: Pembrolizumab |
| Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Part D - BT8009 Monotherapy Supplementary PK | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Part B-8 - BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
| Part B-9 - BT8009 Monotherapy Dose Expansion | Experimental | Participants will receive a selected dose of BT8009. Receives: Drug: BT8009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.
Measured: From cycle 1 day 1 until 30 days after the end of treatment or approximately 1 year
Parts A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 as a monotherapy or in combination with pembrolizumab
Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy or in combination with pembrolizumab.
Measured: 28 days (for cycles that are either 21 or 28 days in length depending on dosing schedule assigned)
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.
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.
Measured: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years
Part D: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year
Part D: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year
Part D: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year
Part D: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year
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.
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.
Measured: From cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 days)
Secondary outcomes (21)
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.
Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving BT8009 as a monotherapy or in combination with pembrolizumab who experience treatment-emergent adverse events using CTCAE v5.0 criteria.
Measured: 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
Duration of objective response (complete or partial response) by RECIST 1.1 in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab
Measured: 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
Proportion of participants who have complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks according to RECIST Version 1.1 criteria.
Measured: 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
Part B: Progression-free survival time to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab.
The time from the first day of study drug administration (Day 1) to disease progression according to RECIST 1.1 criteria in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years
Part B: Overall survival time to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab using RECIST 1.1
The time from start of study drug administration (Day 1) until death due to any cause in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until death, then every 3 months for up to 1 year after last patient accrued
Cohorts B-4, B-5, and B-6: Objective response rate by Nectin-4 status of BT8009 as a monotherapy in patients with selected solid tumor using RECIST 1.1.
Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy according to RECIST 1.1 criteria categorized by Nectin-4 expression status.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years
Parts A-1, A-2, B-8, B-9, and C: Objective response rate to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab.
Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency with confirmed complete response or partial response according to RECIST 1.1 criteria
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death or up to three years
Parts A-1, A-2, C and D: Duration of Response time to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab.
Duration of objective response (complete or partial response) by RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death or up to three years
Parts A-1, A-2, C and D: Clinical benefit rate to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab
Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency who have complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks according to the RECIST Version 1.1 criteria.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression for up to 3 years
Parts A-1, A-2, C and D: Progression-free survival time (months) to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab
The time from start of study drug administration until disease progression according to RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years
Parts A-1, A-2, C and D: Overall survival time (months) to assess preliminary anti-tumor activity of BT8009 as a monotherapy or in combination with pembrolizumab.
The time from start of study drug administration until death due to any cause in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.
Measured: Every 8 weeks for the first 12 months then every 12 weeks until disease progression, then every 3 months for up to 1 year after last patient is accrued
Part A, B and C: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part A, B and C: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part A, B and C: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part A, B and C: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part C: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy.
Plasma concentrations (for impact of renal impairment) of BT8009 and MMAE from Part C participants taking BT8009 as a monotherapy.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part C: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherap.
Plasma concentrations (for impact of renal impairment) of BT8009 and MMAE from Part C participants taking BT8009 as a monotherapy.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part C: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy.
Plasma concentrations (for impact of renal impairment) of BT8009 and MMAE from Part C participants taking BT8009 as a monotherapy.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part C: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy.
Plasma concentrations (for impact of renal impairment) of BT8009 and MMAE from Part C participants taking BT8009 as a monotherapy.
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
All cohorts: Number of participants positive for anti-drug antibodies (ADA) to determine incidence of ADA
Number of participants positive for anti-drug antibodies (ADA) from all participants receiving BT8009 as a monotherapy or in combination with pembrolizumab
Measured: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule)
Part D: Number of participants with treatment emergent adverse events receiving BT8009 as a monotherapy to assess safety and tolerability in participants with normal renal function or mild renal insufficiency.
Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving BT8009 with normal renal function or mild renal insufficiency who experience treatment-emergent adverse events using CTCAE v5.0 criteria.
Measured: From cycle 1 day 1 until at least 30 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start17 Jul 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BicycleTx Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meredith McKean, MD, MPH, Study chair, Tennessee Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561362
- Sponsor's protocol ID
- BT8009-100
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Baldini C, Verlingue L, Goldschmidt V, Doger de Speville B, Lostes J, Italiano A, Cousin S, Falchook GS, Necchi A, Reig Torras O, Fontana E, Carter L, Rodon Ahnert J, Brown JR, DeMars LR, Josephs K, Dickson A, Xu C, Bader J, Campbell C, Sharma R, McKean M. First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation. J Clin Oncol. 2025 Dec 10;43(35):3728-3738. doi: 10.1200/JCO-25-00559. Epub 2025 Nov 6.
PubMed 41197088Klumper N, Eckstein M, Holzel M, Herrmann K, Hadaschik B, Grunwald V. Re: First-in-Human Study of the Radioligand 68Ga-N188 Targeting Nectin-4 for PET/CT Imaging of Advanced Urothelial Carcinoma: Navigating Metastatic Urothelial Cancer with Nectin-4 PET/CT. Eur Urol. 2023 Nov;84(5):514-515. doi: 10.1016/j.eururo.2023.05.029. Epub 2023 Jun 5. No abstract available.
PubMed 37286457