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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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This is a first-in-human, open-label, multicenter, Phase 1a/1b dose escalation dose finding, and dose expansion study to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic solid tumors with the AKT1 E17K mutation, and in combination with fulvestrant in participants with breast cancer that has the AKT1 E17K mutation. This study has a dose escalation and expansion phase with ATV-1601, and an escalation and expansion phase in combination with Fulvestrant.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental/Part 1a: ATV-1601

ATV-1601

Group Type EXPERIMENTAL

ATV-1601

Intervention Type DRUG

Drug: ATV-1601

• Oral ATV-1601

Experimental/Part 1b: ATV-1601 + Fulvestrant

ATV-1601 + Fulvestrant

Group Type EXPERIMENTAL

ATV-1601 + Fulvestrant

Intervention Type COMBINATION_PRODUCT

Drug: ATV-1601

* Oral ATV-1601 Drug: Fulvestrant
* Intramuscular Injection

Interventions

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ATV-1601

Drug: ATV-1601

• Oral ATV-1601

Intervention Type DRUG

ATV-1601 + Fulvestrant

Drug: ATV-1601

* Oral ATV-1601 Drug: Fulvestrant
* Intramuscular Injection

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
2. Have progressed on, were intolerant to, or experienced disease recurrence after standard therapy and have no available effective or tolerable treatment options to derive clinically meaningful benefit.
3. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
5. Measurable disease according to RECIST v1.1 criteria.
6. Formalin-fixed paraffin-embedded tumor specimen available for submission.
7. Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria

1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
2. Inadequate bone marrow reserve or organ function.
3. Clinically significant abnormalities of glucose metabolism.
4. Participants who are symptomatic or have uncontrolled brain metastases.
5. Requires treatment with certain medications.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No