P1/2, N=312, Recruiting, BicycleTx Limited | N=166 --> 312 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023

almost 2 years ago

Enrollment change • Trial completion date • Trial primary completion date

CD4 (CD4 Molecule) • EPHA2 (EPH receptor A2)

Opdivo (nivolumab) • BT5528

2years

Activity of the erythropoietin-producing hepatocellular A2 receptor (EphA2) targeting Bicycle® Toxin Conjugate (BTC™) BCY6033 in EGFR inhibitor resistant non-small lung cancer (NSCLC) patient derived xenografts (AACR 2022)

Here we report on EphA2 expression in well characterized and clinically annotated patient derived xenografts (PDX) of NSCLC including EGFR mutant NSCLC derived either from erlotinib or osimertinib resistant patients. BCY6033 is a potentially promising drug effective against EphA2 expressing PDX models. Future studies and clinical trials will seek to determine the efficacy of BT5528 in EphA2 expressing tumors.

2 years ago

Clinical

EPHA2 (EPH receptor A2)

EGFR mutation

Tagrisso (osimertinib) • erlotinib • BCY6033 • BT5528

3years

[VIRTUAL] Rapid accumulation of cytotoxic payload in tumor tissue drives BT5528 activity in tumor models (AACR 2021)

In contrast, BT5528 achieves prolonged toxin delivery to tumors, following transient exposure in plasma of less than one hour. A Phase I/II study of BT5528 in patients with solid tumors is ongoing, which will investigate if this PK novel, differentiated pharmacokinetic profile, unique to Bicycle toxin conjugates, gives rise to a favorable balance of efficacy and safety.

3 years ago

Preclinical

EPHA2 (EPH receptor A2)

EPHA2 overexpression

BT5528

4years

[VIRTUAL] BT5528-100 phase I/II study of the safety, pharmacokinetics, and preliminary clinical activity of BT5528 in patients with advanced malignancies associated with EphA2 expression. (ASCO 2020)

BT5528-100 (NCT04180371) is a Ph I/II study to evaluate safety and tolerability of weekly BT5528 alone and in combination with Q4W nivolumab. Enrollment is ongoing. Research Funding: Bicycle Tx Limited

4 years ago

Clinical • P1/2 data • PK/PD data • PD(L)-1 Biomarker

EGFR (Epidermal growth factor receptor) • EPHA2 (EPH receptor A2)

Opdivo (nivolumab) • BT5528