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

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.

Participants must meet other inclusion/exclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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