Active — Not RecruitingPhase 1/2

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

United States329 participantsStarted 2020-07-17

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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 * 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). * 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 pr…

What they're measuring

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.

Timeframe: 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

Timeframe: 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.

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT04561362

SponsorBicycleTx Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

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