ATX-295 for Ovarian Cancer

Recruiting at 3 trial locations

Overseen By Jason Sager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Accent Therapeutics

Must not be taking: Proton pump inhibitors, H2-receptor antagonists

Disqualifiers: CNS tumors, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ATX-295, a new oral treatment for ovarian cancer and other advanced solid tumors. The main goal is to find a safe and tolerable dose while assessing the drug's effectiveness against tumors. Participants should have ovarian cancer that has returned, no longer responds to standard treatments, or cannot tolerate such treatments. The trial will involve different groups to determine the best dosing schedule.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like strong or moderate CYP3A4 inhibitors or strong inducers, and you cannot use proton pump inhibitors or H2-receptor antagonists during certain parts of the study. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that ATX-295 is likely to be safe for humans?

Research shows that ATX-295 has produced promising results in early tests. In lab studies, it has been effective against various solid tumors, including ovarian cancer. Although detailed safety information for humans is not yet available, the current research phase focuses on identifying a safe dose. This phase involves careful monitoring to ensure any side effects remain manageable. As this is the first time ATX-295 is being tested in humans, safety remains a top priority. Researchers will closely monitor participants for any side effects while determining the optimal dosage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

ATX-295 is unique because it targets ovarian cancer with a potentially novel mechanism of action, which may offer new hope for patients. Unlike traditional chemotherapy for ovarian cancer, which typically targets rapidly dividing cells, ATX-295 is being evaluated for its ability to work on a molecular level, possibly offering a more precise attack on cancer cells. Researchers are particularly excited because this could lead to fewer side effects and improved outcomes for those who are resistant or intolerant to standard treatments like platinum-based therapies.

What evidence suggests that ATX-295 might be an effective treatment for ovarian cancer?

Research has shown that the drug ATX-295 may help treat ovarian cancer. In early studies, 61% of ovarian cancer models responded to ATX-295, with tumors either stopping growth or shrinking. This trial will explore ATX-295 in different treatment arms, including a Dose Escalation arm to identify optimal dosing and a Dose Expansion arm for patients with platinum-resistant, -refractory, or -intolerant high-grade serous ovarian cancer (HGSOC). The drug blocks KIF18A, a protein involved in cell division, which could help prevent cancer cells from multiplying. Although these findings are preliminary, they offer hope for its potential effectiveness in patients with ovarian cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors or ovarian cancer that have come back or spread and haven't responded to standard treatments, are not suitable candidates for such treatments, or have refused them. Participants should be able to perform daily activities with minimal assistance (ECOG status 0-1) and can have had any number of prior treatments.

Inclusion Criteria

My cancer has returned or spread, including high-grade serous ovarian cancer.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer did not respond to or has come back after all standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D

12 months

Dose Expansion

Further examination of the safety and PK of ATX-295 at the RP2D in patients with platinum-resistant, -refractory, or -intolerant HGSOC

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ATX-295

Trial Overview The study tests ATX-295, a new oral medication aimed at inhibiting KIF18A—a protein involved in cell division. The main goals are to find the highest dose patients can take without serious side effects, understand how the body processes the drug, and see if it helps control tumor growth.

How Is the Trial Designed?

Group I: Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOC Experimental Treatment 1 Intervention

Group II: Dose Escalation Experimental Treatment 1 Intervention

Subjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D

Who Is Running the Clinical Trial?

Accent Therapeutics

Lead Sponsor

Trials

2

Recruited

170+

Published Research Related to This Trial

In a study of 128 patients with advanced epithelial ovarian cancer, those who underwent primary surgery had a significantly better progression-free survival (PFS) of 56 months compared to 39 months for those who received neoadjuvant chemotherapy (NACT), indicating that primary surgery may be more effective for treatment.

Patients who achieved optimal debulking (no residual disease) after primary surgery had an even greater PFS of 59 months, compared to 38 months for those who had NACT, suggesting that optimal surgical intervention is crucial for improving survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment pattern and outcomes in epithelial ovarian cancer patients from a cancer institute in Kerala, India. Georgeena, P., Rajanbabu, A., Vijaykumar, DK., et al.[2022]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3784/761181/Abstract-3784-Activity-of-the-novel-KIF18A

Abstract 3784: Activity of the novel KIF18A inhibitor, ATX-295 ... 61% of ovarian models responded to ATX-295 with tumor stasis or better, supportive of robust efficacy in ovarian cancer. Within responding PDX ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06799065

NCT06799065 | First-in-Human Study of ATX-295, an Oral ... ATX-295 has been shown preclinically to induce robust anti-tumor activity of a variety of different solid tumors, including high-grade serious ovarian cancer ...

3. accenttx.com accenttx.com/news-events/accent-therapeutics-announces-first-patient-dosed-in-phase-1-2-trial-of-novel-kif18a-inhibitor-atx-295/

First-in-human Phase 1/2 study initiated for ATX-295, ... The trial is enrolling patients with locally advanced or metastatic solid tumors, including high-grade serious ovarian cancer. The initiation of ...

4. withpower.com withpower.com/trial/phase-1-triple-negative-breast-neoplasms-3-2025-56781

ATX-295 for Ovarian Cancer In a study of 128 patients with advanced epithelial ovarian cancer, those who underwent primary surgery had a significantly better progression-free survival ( ...

5. researchgate.net researchgate.net/publication/390996229_Abstract_3784_Activity_of_the_novel_KIF18A_inhibitor_ATX-295_is_enriched_in_whole_genome_doubled_ovarian_cancer_pre-clinical_models

Activity of the novel KIF18A inhibitor, ATX-295, is enriched ... 61% of ovarian models responded to ATX-295 with tumor stasis or better, supportive of robust efficacy in ovarian cancer. Within responding PDX ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=914b4014-d9eb-4651-83c3-b81e015c6b1a

ATX-295 / Accent Therap Activity of the novel KIF18A Inhibitor, ATX-295, is enriched in whole genome doubled ovarian and TNBC preclinical models (AACR-NCI-EORTC 2025) - P1 ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0140551

High-grade Serous Ovarian Carcinoma (HGSOC) ... First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer. ATX-295.