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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 20, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT04561362). This is a study registration, not published results. Lead sponsor: BicycleTx Limited. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 329 participants (ESTIMATED). 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, Ovarian Neoplasm, Advanced Solid Tumor. Interventions: DRUG: BT8009; DRUG: Pembrolizumab. Primary outcome measures: 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; 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); 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; 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; 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; 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; 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; 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). Brief 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 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).