BT8009

P2/3, N=956, Recruiting, BicycleTx Limited

P1/2, N=329, Recruiting, BicycleTx Limited

BT8009 was well tolerated and demonstrated promising preliminary antitumor activity. Evaluation of BT8009 as monotherapy at RP2D(s) and in combination with an immune checkpoint inhibitor will be explored during the expansion phase of this trial; cohorts will include pts with renal impairment to support further development in cis-ineligible pts, pts with previously untreated cis-ineligible metastatic UC, pts with refractory UC, and tumor-specific cohorts outside of bladder cancer. Clinical trial information: NCT04561362.

P1/2, N=329, Recruiting, BicycleTx Limited | N=172 --> 329 | Trial completion date: Jun 2023 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2025

Multiple tumor types overexpress Nectin-4 and the Antibody Drug Conjugate (ADC), enfortumab vedotin (EV) shows striking efficacy in clinical trials for metastatic urothelial cancer, which expresses high levels of Nectin-4, validating Nectin-4 as a clinical target for toxin delivery in this indication. These physical and PK characteristics differentiate BT8009 from ADCs and may provide benefit in terms of tumor penetration and reduced systemic exposure. BT8009 is currently in a Phase 1/2 multicenter clinical trial across the USA, Canada and Europe, enrolling patients with advanced solid tumors associated with Nectin-4 expression.

Here, we describe the preliminary monotherapy dose escalation results of the ongoing multicenter Phase I/II clinical trial (NCT04561362) that assesses the safety and tolerability of BT8009 administration in patients with advanced solid tumors associated with Nectin-4 expression, not exposed to enfortumab vedotin. BT8009 exhibits a promising preliminary tolerability profile and preliminary antitumor activity. The molecule will continue to be explored in the current dose-escalation/dose-expansion study of BT8009 monotherapy and in combination with nivolumab.

The Nectin-4 targeted enfortumab vedotin, linked to MMAE via a val-cit linker, is highly active in late-stage bladder cancer and demonstrates notable additional clinical activity as a single agent and in combination with pembrolizumab1... Study BT8009-100 (NCT04561362) will evaluate safety and tolerability of weekly and every other week BT8009 administration, alone and in combination with q4w nivolumab...PK serial collections will be taken on D1 through D15 . Radiologic tumor assessments for response per RECIST will be taken every two months.