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Breast Carcinoma / ATV-1601 / Advanced Solid Tumors · Phase 1 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for ATV-1601, a novel oral AKT1 inhibitor, in patients with AKT1 E17K-mutant advanced solid tumors and HR+/HER2− breast cancer. The study is designed to determine safety, tolerability, maximum tolerated dose, and pharmacokinetics, with or without the endocrine agent fulvestrant. No efficacy or safety results have been posted in this registry record.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers, Cervical Neoplasms, Cervical Carcinoma,…; age from 18 Years. Intervention: Experimental/Part 1a: ATV-1601; Experimental/Part 1b: ATV-1601 + Fulvestrant. n = 134. 8 sites across 4 countries.
This is a Phase 1 trial registration for ATV-1601, a novel oral AKT1 inhibitor, in patients with AKT1 E17K-mutant advanced solid tumors and HR+/HER2− breast cancer. The study is designed to determine safety, tolerability, maximum tolerated dose, and pharmacokinetics, with or without the endocrine agent fulvestrant. No efficacy or safety results have been posted in this registry record.
Registry record contains no reported safety or efficacy results; study is active but not yet recruiting. Pharmacokinetic endpoints (Cmax, AUC, half-life) are planned but not yet reported.
This trial is in early stages and has not yet reported efficacy or safety outcomes. Clinicians should monitor for future publications of Phase 1 data to understand the safety profile, recommended dosing, and preliminary tolerability of ATV-1601 before considering participation in or interpretation of later-phase trials.
Phase 1 trial registration with no results reported; study is active but not yet recruiting, evaluating safety and dosing of a novel AKT1 inhibitor in advanced cancers.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early stages and has not yet reported efficacy or safety outcomes. Clinicians should monitor for future publications of Phase 1 data to understand the safety profile, recommended dosing, and preliminary tolerability of ATV-1601 before considering participation in or interpretation of later-phase trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07038369). This is a study registration, not published results. Lead sponsor: Atavistik Bio, Inc. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 134 participants (ESTIMATED). Conditions: Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers, Cervical Neoplasms, Cervical Carcinoma, Triple Negative Breast Cancer, Gynecologic Cancers, Gynecologic Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Endometrial Carcinoma (EC), Fallopian Cancer, Ovarian Carcinoma, Ovarian Cancer, Ovarian Neoplasms, Prostate Cancers, Prostate Carcinoma, Solid Tumors, Neoplasms, Neoplasms by Site, Breast Diseases, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms. Interventions: DRUG: ATV-1601; COMBINATION_PRODUCT: ATV-1601 + Fulvestrant. Primary outcome measures: Expansion: Maximum and minimum plasma concentration , Approximately 48 months.; Expansion: Time to C Max , Approximately 48 months; Expansion: Area under the concentration-time curve , Approximately 48 months; Expansion: AUC at end of dosing interval , Approximately 48 months; Expansion: AUC extrapolated to infinity , Approximately 48 months; Expansion: Half-life , Approximately 48 months; Expansion: Trough Concentrations , Approximately 48 months; Escalation & Expansion: Safety and Tolerability of monotherapy. , Approximately 48 months.; Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy. , Approximately 48 months.; Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant. , Approximately 48 months.. Brief summary: This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with or without fulvestrant.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.