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NCT07038369 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

A Phase 1 study of Breast Cancer and Advanced Solid Tumors, sponsored by Atavistik Bio.

Active
Registry status
Phase 1
Development phase
134
Enrollment target
8
Study locations

NCT07038369 is a Phase 1 study of Breast Cancer and Advanced Solid Tumors that is active but no longer recruiting, run by Atavistik Bio. The registered enrollment target is 134 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT07038369, a Phase 1 study of Breast Cancer and Advanced Solid Tumors, is active but no longer recruiting, sponsored by Atavistik Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
134 participants
Enrollment target
8
Study locations

Study 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.

Conditions Studied

Breast Cancer Advanced Solid Tumors Triple Negative Breast Cancer Breast Carcinoma Breast Neoplasms Cervical Carcinoma Gynecologic Cancers ER Positive Breast Cancer Cervical Cancers Cervical Neoplasms

Interventions

  • DRUG ATV-1601
  • COMBINATION_PRODUCT ATV-1601 + Fulvestrant

Study Locations (8)

Other

  • Centre Leon Berard - Lyon
  • National Cancer Centre Singapore - Singapore
  • START Madrid - CIOCC - Madrid

California

  • USC Norris Comprehensive Cancer Center - Los Angeles

Florida

  • Florida Cancer Specialists & Research Institute - Lake Mary - Lake Mary

Massachusetts

  • Massachusetts General Hospital - Boston

Missouri

  • Washington University - St Louis

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2025-07-29
Est. Completion 2029-01-31
Phase Phase 1

Sponsor

Atavistik Bio

1 total trials

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What the Registry Record Tells You About NCT07038369

The ClinicalTrials.gov registry entry for NCT07038369 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Atavistik Bio, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which ATV-1601 is the first listed.

NCT07038369 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT07038369 about?

NCT07038369 is a clinical study titled "A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations". 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.

What is the current status of trial NCT07038369?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2025-07-29. Estimated completion is 2029-01-31.

What conditions does trial NCT07038369 study?

This clinical trial studies the following conditions: Breast Cancer, Advanced Solid Tumors, Triple Negative Breast Cancer, Breast Carcinoma, Breast Neoplasms.

What interventions are being tested in trial NCT07038369?

The interventions under investigation include: ATV-1601 (DRUG), ATV-1601 + Fulvestrant (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT07038369?

This trial is sponsored by Atavistik Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07038369 being conducted?

This trial has 8 study locations across California, Florida, Massachusetts, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.