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

Trial Summary

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.

What data supports the effectiveness of the drug ATX-295 for ovarian cancer?

The research on the LXR agonist T0901317, which is similar to ATX-295, shows it can stop ovarian cancer cells from growing and help them die, suggesting potential effectiveness for ATX-295 in treating ovarian cancer. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Anti-proliferative effect of LXR agonist T0901317 in ovarian carcinoma cells. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Surgical treatment pattern and outcomes in epithelial ovarian cancer patients from a cancer institute in Kerala, India. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Assessment of risk factors for 30-day hospital readmission after surgical cytoreduction in epithelial ovarian carcinoma. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Medical therapy of advanced malignant epithelial tumours of the ovary. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Why have ovarian cancer mortality rates declined? Part II. Case-fatality. [2015]