EC1169 / Novartis - LARVOL DELTA

Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC) (ESMO 2017) - P1; "The utility of the PSMA-targeted companion imaging agent 99mTc-EC0652 is also being evaluated as a patient selection tool. The RP2 dose of EC1169 is 6.5 mg/m2 (D1, 8 every 21 days). EC1169 has been well tolerated in 34 Part B pts at the RP2 dose A PSMA-targeted therapeutic strategy appears viable. There is evidence of anti-tumor activity in both the taxane naïve and taxane exposed pts."

Biomarker • Clinical • P1 data • Prostate Cancer

Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC). (ASCO 2017) - P1; " Part A pts were eligible if they progressed on abiraterone or enzalutamide, and were treated with a taxane. The RP2 dose of EC1169 is 6.5 mg/m2. EC1169 has been well tolerated in 20 pts at the RP2 dose. Imaging with 99mTc-EC0652 suggests excellent disease localization supporting a PSMA-targeted therapeutic strategy."

Biomarker • Clinical • P1 data • Biosimilar • Immunology • Prostate Cancer • Venous Thromboembolism

"@morr316 Phase I study of the PSMA-targeted small-molecule drug conjugate EC1169 in mCRPC @zklaassen_md #ESMO17 https://t.co/NsTE31xiDJ" (@urotoday)

P1 data • Biosimilar • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Phase 1 of EC1169 in patients with recurrent MCRPC (clinicaltrials.gov) - KOL: Michael Morris; Daniel Petrylak; Nicholas Vogelzang; P1, N=40; Recruiting; Sponsor: Endocyte; Trial primary completion date: Sep 2016 ➔ Jun 2017.

Trial primary completion date • Prostate BR • Prostate Cancer • Prostate Cancer KOL Tracker

Phase 1 of EC1169 In Patients With Recurrent MCRPC (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Endocyte; Trial primary completion date: Sep 2015 ➔ Sep 2016

Trial primary completion date • Biosimilar • Oncology • Prostate Cancer

PSMA-specific antitumor activity of a self-immolative tubulysin conjugate. (PubMed, Bioconjug Chem) - "One of these compounds, EC1169, emerged as a lead candidate for preclinical development and phase 1 clinical testing. Finally, treatment of LNCaP-bearing mice with docetaxel (the most active chemotherapeutic agent approved for late stage prostate cancer therapy), was found to produce only modest anti-tumor activity, and this outcome was also associated with severe weight loss. Taken together, these results strongly indicate that PSMA-positive tumors may be effectively treated using highly potent, PSMA-targeted small-molecule drug conjugates using regimens that do not cause undesirable side effects."

Biomarker • Journal

Phase 1 of EC1169 In Patients With Recurrent MCRPC (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Endocyte; Active, not recruiting ➔ Completed

Clinical • Trial completion