ATV-1601 for Breast Cancer

Recruiting at 14 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Atavistik Bio, Inc

Disqualifiers: KRAS, NRAS, HRAS, BRAF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new oral treatment, ATV-1601, for individuals with advanced solid tumors or a specific type of advanced breast cancer. It consists of two parts: one testing ATV-1601 alone and another testing it in combination with fulvestrant, a hormone therapy for breast cancer. Ideal candidates for this trial have cancer with a specific genetic mutation (AKT1 E17K) and have not responded to standard treatments. Participants should have advanced cancer that is measurable and lack effective treatment options. As a Phase 1 trial, this research focuses on understanding how ATV-1601 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that participants who require treatment with certain medications may be excluded, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ATV-1601 is likely to be safe for humans?

Research has shown that ATV-1601 looks promising in early studies. Initial findings suggest it might be safer and more effective than other similar treatments, helping to shrink tumors in certain types of breast and endometrial cancer.

Currently, ATV-1601 is being tested in a Phase 1 trial, the first stage of testing in humans. This stage primarily aims to determine the treatment's safety and tolerability. While early results are encouraging, more information is needed to fully understand its safety profile.

Researchers are also examining how ATV-1601 works when combined with fulvestrant, a hormone therapy already used for some breast cancers, to see if adding ATV-1601 could be beneficial. However, since this is a Phase 1 trial, the focus remains on safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ATV-1601 because it offers a new approach to treating breast cancer. Unlike traditional treatments such as chemotherapy or hormone therapies like tamoxifen, ATV-1601 may work by targeting specific pathways involved in cancer cell growth, potentially leading to more precise treatment with fewer side effects. Additionally, when combined with Fulvestrant, a hormone therapy, ATV-1601 might enhance the effectiveness of current hormone treatments by overcoming resistance mechanisms in cancer cells. This dual approach could provide new hope for patients whose cancer doesn't respond to existing therapies.

What evidence suggests that ATV-1601 might be an effective treatment for breast cancer?

Research has shown that ATV-1601, which participants in this trial may receive, has shown promise in early studies for certain types of breast cancer. It effectively shrank tumors and provided long-lasting effects in ER+/HER2- (a type of hormone-sensitive breast cancer) and triple-negative breast cancer. ATV-1601 blocks a specific pathway that aids cancer cell growth. In this trial, some participants will receive ATV-1601 alone, while others will receive it combined with fulvestrant, a drug that blocks estrogen. This combination might offer even stronger effects. Although human studies provide limited information, these early results suggest it could effectively treat these breast cancers. ^{1 2 3 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Atavistik Bio

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific mutation called AKT1 E17K. It's also for those with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Participants must be able to take oral medication.

Inclusion Criteria

My cancer has a specific AKT1 E17K mutation.

Measurable disease according to RECIST v1.1 criteria

I have a preserved tumor sample available for testing.

Exclusion Criteria

Clinically significant abnormalities of glucose metabolism

My bone marrow or organs are not functioning well.

I need to take specific medications for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ATV-1601 as monotherapy or in combination with fulvestrant to determine the maximum tolerated dose

Approximately 48 months

Dose Expansion

Participants receive ATV-1601 to evaluate safety, tolerability, and preliminary antitumor activity

Approximately 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ATV-1601

Trial Overview The study tests ATV-1601, an oral drug, alone and in combination with Fulvestrant, which is used to treat certain types of breast cancer. The goal is to see how safe and tolerable these treatments are for patients.

How Is the Trial Designed?

Group I: Experimental/Part 1b: ATV-1601 + Fulvestrant Experimental Treatment 1 Intervention

ATV-1601 + Fulvestrant

Group II: Experimental/Part 1a: ATV-1601 Experimental Treatment 1 Intervention

ATV-1601

Who Is Running the Clinical Trial?

Atavistik Bio, Inc

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07038369

NCT07038369 | A Phase 1 Study of ATV-1601 in Patients ... 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 ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/LB008/761582/Abstract-LB008-ATV-1601-a-potent-and-selective

Abstract LB008: ATV-1601, a potent and selective allosteric ... ATV-1601 demonstrated profound tumor regressions with long durations in ER+/HER2- and triple negative breast cancer and endometrial AKT1E17K ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/atavistik-bio-atv-1601/

Atavistik doses first subject in trial of ATV-1601 for solid ... Atavistik Bio has dosed the first subject in its Phase I clinical trial of ATV-1601, designed to treat adults with solid tumours.

4. atavistikbio.com atavistikbio.com/programs/

Programs 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 ...

5. synapse.patsnap.com synapse.patsnap.com/article/atavistik-bio-presents-preclinical-data-on-atv-1601-at-eortc-nci-aacr-symposium

Atavistik Bio Presents Preclinical Data on ATV-1601 at ... The findings highlight ATV-1601's enhanced target inhibition, superior efficacy, and better tolerability compared to pan-AKT inhibitors in ...

6. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT07038369

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, effects (good and bad), and anti-cancer activity of ATV-1601 targeted therapy. Who is this for?: