ATV-1601 / Atavistik Bio - LARVOL DELTA

ATV-1601-102: Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Atavistik Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

Atavistik Bio…announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for the Harmony-HHT study, a Phase 1/2 trial evaluating ATV-1601 in individuals with moderate to severe Hereditary Hemorrhagic Telangiectasia (The Manila Times) - "In addition to the IND clearance, Atavistik Bio also announced that ATV-1601 has been granted Fast Track Designation by the FDA. The FDA’s clearance of the Harmony-HHT Phase 1/2 study design allows Atavistik Bio to leverage existing clinical data with ATV-1601 and proceed directly into a randomized study. "

Fast track • IND • Trial status • Genetic Disorders

Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Atavistik Bio, Inc

New P1/2 trial • Hematological Disorders

ATV-1601, a potent and selective allosteric inhibitor of AKT1E17K, demonstrates profound and durable regressions in multiple patient and cell derived xenograft models [WITHDRAWN] (AACR 2025) - "Abstract is embargoed at this time."

Late-breaking abstract • Preclinical • Oncology

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Recruiting | Sponsor: Atavistik Bio Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Recruiting | Sponsor: Atavistik Bio Inc.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

ATV-1601-101: A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations (clinicaltrialsregister.eu) - P1 | N=64 | Active, not recruiting | Sponsor: Atavistik Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Active, not recruiting | Sponsor: Atavistik Bio, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Breast Cancer • Cervical Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer • AKT1 • HER-2

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Atavistik Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cervical Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer

Atavistik Bio Announces First Patient Dosed in Phase 1 Clinical Trial of ATV-1601 in Patients with AKT1 E17K-mutant Solid Tumors (GlobeNewswire) - "Atavistik Bio...announced the dosing of the first patient in its Phase 1 study of ATV-1601 in adults with AKT1 E17K-mutant solid tumors....The first-in-human, open-label Phase 1a/1b study (NCT07038369) will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic AKT1 E17K-mutant solid tumors, and in combination with fulvestrant in participants with AKT1 E17K-mutant HR-positive/HER2-negative breast cancer."

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov) - P1 | N=134 | Not yet recruiting | Sponsor: Atavistik Bio, Inc

New P1 trial • Breast Cancer • Cervical Cancer • Endometrial Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urology • Uterine Cancer

ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1E17K and Shows Profound and Durable Regressions in AKT1E17K-Driven Patient Derived Xenograft Models (SABCS 2024) - "ATV-1601 demonstrates exceptional efficacy with a favorable in vivo tolerability profile and data supports advancing toward clinical development."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer • AKT2 • ER • HER-2 • PLEK

ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1-E17K and Shows Profound and Durable Regressions in AKT1-E17K-Driven Patient Derived Xenograft Models (EORTC-NCI-AACR 2024) - "ATV-1601 demonstrates exceptional efficacy with a favorable in vivo tolerability profile and data supports advancing toward clinical development."

Preclinical • Brain Cancer • Breast Cancer • CNS Tumor • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Meningioma • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • AKT1 • AKT2 • ER • HER-2 • PLEK

Atavistik Bio Presents Preclinical Data on Precision Oncology Development Candidate, ATV-1601, a Selective Allosteric AKT1 E17K Small Molecule Inhibitor, at EORTC-NCI-AACR Symposium (GlobeNewswire) - "Atavistik Bio...presented preclinical data at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting 2024 in Barcelona for ATV-1601, the company’s orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers. The preclinical data demonstrated that as a selective allosteric AKT1 E17K inhibitor, ATV-1601 provides enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors in preclinical models. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K mutant tumors in early 2025."

New trial • Preclinical • Solid Tumor

Atavistik Bio Announces Nomination of Precision Oncology Development Candidate, ATV-1601, a Selective Allosteric AKT1 E17K Small Molecule Inhibitor (GlobeNewswire) - "Atavistik Bio...announced its precision oncology development candidate ATV-1601, an orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers....Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025....Preclinical data on ATV-1601 to be presented at the EORTC-NCI-AACR Symposium on October 23, 2024."

New molecule • New trial • Oncology