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

Atavistik Bio, Inc

Status and phase

Enrolling

Phase 1

Conditions

Ovarian Neoplasms

Ovarian Carcinoma

Breast Neoplasms

Gynecologic Cancers

Solid Tumors

Cervical Carcinoma

Fallopian Cancer

Endometrial Cancer

Gynecologic Neoplasm

Uterine Neoplasms

Breast Diseases

Prostate Carcinoma

Breast Cancer

Neoplasms by Site

Genital Neoplasms, Female

Ovarian Cancer

Cervical Neoplasms

Endometrial Carcinoma (EC)

ER Positive Breast Cancer

Neoplasms

Advanced Solid Tumors

Prostate Cancers

Urogenital Neoplasms

Endometrial Neoplasm

Triple Negative Breast Cancer

Cervical Cancers

Breast Carcinoma

Treatments

Drug: ATV-1601

Combination Product: ATV-1601 + Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT07038369

ATV-1601-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

134 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
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.
Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
Measurable disease according to RECIST v1.1 criteria.
Formalin-fixed paraffin-embedded tumor specimen available for submission.
Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion criteria

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

Participants must meet other inclusion/exclusion criteria.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

Experimental/Part 1a: ATV-1601

Experimental group

Description:

ATV-1601

Treatment:

Drug: ATV-1601

Experimental/Part 1b: ATV-1601 + Fulvestrant

Experimental group

Description:

ATV-1601 + Fulvestrant

Treatment:

Combination Product: ATV-1601 + Fulvestrant

Trial contacts and locations

Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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