AC0176 / Accutar Biotech - LARVOL DELTA

PROTAC'ing the androgen receptor and other emerging therapeutics in prostate cancer. (PubMed, Expert Rev Anticancer Ther) - "PROTACs, DAARIs, and anitens represent novel and promising AR-targeting therapeutics that may become an important part of prostate cancer treatment in the future. Elucidating mechanisms of resistance, including ability of these agents to target full length AR, may yield further insights into maximal therapeutic efficacy aimed at silencing AR signaling."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Targeted Protein Degradation • AR

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=28 | Terminated | Sponsor: Accutar Biotechnology Inc | Trial completion date: Nov 2024 ➔ Mar 2024 | Active, not recruiting ➔ Terminated; Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study

Metastases • Trial completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Accutar Biotechnology Inc | Trial completion date: Jan 2026 ➔ Oct 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Oct 2023; Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study

Metastases • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Recruiting ➔ Active, not recruiting | N=150 ➔ 8

Enrollment change • Enrollment closed • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Nov 2024 | Trial primary completion date: Mar 2023 ➔ Apr 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Accutar Biotechnology Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Accutar Biotechnology Announces First Patient Dosed in China with AC0176 in Phase 1 Study in Prostate Cancer (Businesswire) - "Accutar Biotechnology, Inc...announces the dosing of the first patient in China in a Phase 1 study of AC0176, an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity....The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with metastatic Castration Resistant Prostate Cancer (mCRPC)."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Accutar Biotechnology Inc

Metastases • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0176 in Prostate Cancer (Businesswire) - "Accutar Biotechnology...announces that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic Castration Resistant Prostate Cancer (mCRPC)....The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with mCRPC. Accutar expects to begin enrollment of this study in the second half of this year."

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Accutar Biotechnology Announces Fast Track Designation Granted by FDA to AC0176 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (Businesswire) - "Accutar Biotechnology...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AC0176 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) with disease progression on or after treatment with androgen receptor signaling inhibitors. AC0176 is an orally bioavailable, chimeric degrader molecule targeting the androgen receptor (AR)."

Fast track designation • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Accutar Biotechnology Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Accutar Biotechnology Announces First Patient Dosed with AC0176 in Phase 1 Study in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (Businesswire) - "Accutar Biotechnology...announced the dosing of the first patient in a Phase 1 study of AC0176, an orally bioavailable, chimeric degrader molecule designed to target the androgen receptor (AR) with high potency and selectivity....The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in patients with mCRPC."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Accutar Biotechnology Inc

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0176 in Prostate Cancer (Businesswire) - "Accutar Biotechnology, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)...Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0176 in the first quarter of 2022...The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in mCRPC patients."

IND • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor