ART4215 / Artios Pharma - LARVOL DELTA

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=390 | Active, not recruiting | Sponsor: Artios Pharma Ltd | Trial completion date: Aug 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=390 | Active, not recruiting | Sponsor: Artios Pharma Ltd | Phase classification: P1/2 ➔ P1 | Trial completion date: Jan 2026 ➔ Aug 2025 | Trial primary completion date: Aug 2025 ➔ Mar 2025

Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=390 | Active, not recruiting | Sponsor: Artios Pharma Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Jan 2026 | Trial primary completion date: Mar 2025 ➔ Aug 2025

Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=290 | Recruiting | Sponsor: Artios Pharma Ltd | N=206 ➔ 290

Enrollment change • Metastases • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2 • TP53BP1

Phase 2 Trial of ART4215 and Talazoparib Initiated in BRCA Deficient Breast Cancer (Targeted Oncology) - "Based on findings from the interim phase 1 portion of a trial examining ART4215 in combination with talazoparib in BRCA deficient breast cancer, a phase 2 portion will be initiated. A phase 2 study (NCT04991480) evaluating the combination of ART4215 and talazoparib (Talzenna) has been initiated in an expansion study for the treatment of patients with BRCA deficient breast cancer, according to Artios Pharma Limited....'Patients with advanced solid tumors have achieved improved outcomes with the development of PARP inhibitors. However, there is still a need to address resistance mechanisms diminishing initial tumor responses and leading to disease progression. ART4215 has the potential to help overcome these limitations, and we are excited that the initiation of this phase 2 trial represents an important step in the clinical evaluation of Polo as a novel target,' said Erika P. Hamilton."

Media quote

Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination with PARP Inhibitor Talazoparib in BRCA Deficient Breast Cancer (GlobeNewswire) - "Phase 1 safety and tolerability data for ART4215 in advanced solid tumors is expected in 1H 2023; Phase 2 data in BRCA deficient breast cancer is expected in 2024. Artios Pharma Limited...announces it has initiated a Phase 2 study with ART4215, a small molecule inhibitor of polymerase theta (Polθ) in combination with talazoparib (TALZENNA), an oral poly (ADP-ribose) polymerase (PARP) inhibitor in an expansion study for the treatment of BRCA deficient breast cancer....A recommended Phase 2 dose has been established for ART4215 in combination with talazoparib, and a randomized expansion cohort has been initiated to evaluate the combination in patients with BRCA deficient breast cancer. The study will enroll up to 206 patients and will be conducted at multiple oncology centers across the USA and Europe."

P1 data • P2 data • Trial status • Breast Cancer • Oncology • Solid Tumor • BRCA

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=206; Recruiting; Sponsor: Artios Pharma Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2 • TP53BP1

Artios Doses First Patient in Phase 1/2a Study of Polθ Inhibitor ART4215 - P1/2, N=206; NCT04991480; Sponsor: Artios Pharma Ltd; "The open label, multi-center study will assess the safety, tolerability, pharmacokinetics, and clinical activity of ART4215 administered orally as a monotherapy and in combination with other anticancer medicines in patients with advanced or metastatic solid tumors. The study will enroll up to 206 patients and will be conducted at multiple oncology centers across the USA and Europe. The trial is led by principal investigators Erika P. Hamilton...Timothy Yap, M.B.B.S., Ph.D..."

P1/2 data

Artios Doses First Patient in Phase 1/2a Study of Polθ Inhibitor ART4215 (GlobeNewswire) - "Artios Pharma Limited...announces it has dosed the first patient in its Phase 1/2a study with its polymerase theta (Polθ) inhibitor, ART4215....The open label, multi-center study will assess the safety, tolerability, pharmacokinetics, and clinical activity of ART4215 administered orally as a monotherapy and in combination with other anticancer medicines in patients with advanced or metastatic solid tumors. The study will enroll up to 206 patients and will be conducted at multiple oncology centers across the USA and Europe....Interim safety and tolerability data is expected in 2022."

P1/2 data • Trial status • Oncology • Solid Tumor

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=206; Not yet recruiting; Sponsor: Artios Pharma Ltd

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2 • TP53BP1

Artios Pharma Announces the Start of First Clinical Study with the Dosing of its ATR Inhibitor, ART0380, to Patients (PRNewswire) - “Artios Pharma…announced the start of a clinical trial of its small-molecule ATR inhibitor, ART0380, in patients with advanced or metastatic solid tumors…The clinical trial of the ATR (Ataxia telangiectasia and Rad3-related kinase) inhibitor is an open-label, multi-center, Phase I/IIa study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART0380 as a monotherapy and in combination with gemcitabine in patients with advanced or metastatic solid cancers. The study will enroll up to 180 patients and will be conducted at multiple oncology centers across the USA, UK, and Europe…ART0380 and ART4215, a first in class Pol theta inhibitor, in the clinic by end of 2021...Melissa Johnson, MD...said: 'We have a strong heritage in developing novel cancer therapies. We see DDR as an exciting and promising area of research and are excited to collaborate with Artios on this important clinical trial.'"

Media quote • Trial status • Oncology • Solid Tumor