Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies - n.a

BicycleTx Limited0 sites146 target enrollmentMay 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

May 20, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1 Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study\-specific procedures, sampling, or analyses.
•2 At least 18 years\-of\-age at the time of signature of the informed consent form.
•3 ECOG Performance Status score of 0 or 1\.
•4Patients must have measurable disease per RECIST v1\.1\.
•5Acceptable organ function, as evidenced by the following laboratory data:
•a Renal function, as follows: creatinine clearance of \=50 mL/min by the Cockcroft\-Gault equation or equivalent.
•b Total bilirubin \=1\.5 × ULN
•cSerum albumin \=2\.5 g/dL
•d AST \=2\.5 × ULN or \=5 × ULN in the presence of liver metastases
•e ALT \=2\.5 × ULN or \=5 × ULN in the presence of liver metastases

•1\. Chemotherapy treatments within 14 days prior to first dose, other anticancer treatments, treatment within 28 days or 5 terminal half\-lives, whichever is shorter. Prior toxicities must have resolved to G1 CTCAE v5\.0 (except alopecia, which must be no greater than G2\).
•2\. Experimental treatments within 4 weeks of first dose
•3\. Prior treatment with Nectin\-4 targeted therapy
•4\. Current treatment with strong inhibitors or strong inducers of CYP3A4 or strong inhibitors of P\-gp, including herbal\- or food\-based.
•5\. Known sensitivity to any of the ingredients of BT8009 or monomethyl auristatin E
•6\. BSA \>2\.21 m2
•7\. Significant condition, including but not limited to eye (dry eye, corneal opacities or keratitis), skin (rash ), life\-threatening illness, active uncontrolled infection or organ system dysfunction, or other reasons in the Investigator opinion. Prior \= Grade 2 thyroid endocrinopathy is allowed, if appropriately controlled with thyroid hormone and stable for at least 2 months on therapy
•8\. relevant troponin elevation.
•9\. Uncontrolled diabetes(HbA1c \=8%)
•10\. Major surgery (excluding placement of vascular access) within 4 weeks and recovered adequately prior to 1st dose