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RecruitingPhase 1 / Phase 2

First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ATX-295, a drug taken by mouth, alone or with bevacizumab or a similar drug. It aims to find a safe dose, learn how the drug works in the body, and see if it may fight cancer. It is for people with solid tumors that have grown nearby or spread, including ovarian and lung cancer.

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 as a monotherapy and in combination with bevacizumab (or a biosimilar) in patients with locally advanced or metastatic solid tumors, including ovarian cancer and lung cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid tumor confirmed by a tissue test, with cancer that has returned nearby or spread to other parts of the body.
  • Standard treatments have not worked or cancer has returned after them. You may also qualify if no standard treatment exists, the study doctor says it is not suitable, or you decline it after understanding your options.
  • For the ovarian cancer groups testing ATX-295 alone: have high-grade serous ovarian cancer, a type of ovarian cancer, that resists platinum chemotherapy or you cannot tolerate that treatment.
  • For the squamous non-small cell lung cancer groups testing ATX-295 alone: have had platinum and taxane chemotherapy and a checkpoint inhibitor, a drug that helps the immune system fight cancer.
  • For treatment with bevacizumab or a similar drug: have high-grade serous ovarian cancer or another selected solid tumor confirmed by a tissue test.
  • There is no limit on the number of past cancer treatments.
  • Have cancer that can be measured. During the dose-finding part, cancer that can be assessed in other ways is also allowed.
  • Be fully active or able to do light work despite limits on hard physical activity. Other study rules also apply.

Who can't join

  • Have tumors in the brain or spinal cord, or cancer that has spread to the brain, that are not medically stable.
  • Are getting another cancer treatment at the same time, except treatment that blocks hormones.
  • Had major surgery within 3 weeks before starting study treatment.
  • Have trouble taking medicine by mouth or a digestive problem that could greatly reduce drug absorption. A working ileostomy or colostomy, a surgically made opening for stool, may be allowed.
  • Have active, medically serious or uncontrolled heart or blood vessel disease.
  • Need proton pump inhibitors, medicines that reduce stomach acid, during the study, or H2 blockers, another type of acid reducer, during the dose-finding part.
  • Cannot stop certain medicines that strongly or moderately block CYP3A4, a protein that breaks down drugs, or strongly increase its activity.
  • Are pregnant or plan to breastfeed or conceive a child during the expected treatment period.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC * Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit * For the monotherapy expansion cohorts: * Participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, or platinum-intolerant * Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor * For the combination with bevacizumab (or biosimilar): Participants must have histologically confirmed HGSOC or select solid tumors * There is no limit to the number of prior treatment regimens * Have measurable disease; evaluable disease is acceptable during dose escalation * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Key Exclusion Criteria: * Clinically unstable central nervous system (CNS) tumors or brain metastasis * Any other concurrent anti-cancer treatment, except for hormonal blockade * Has undergone a major surgery within 3 weeks of starting study treatment * Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial * Clinically significant (ie, active) or uncontrolled cardiovascular disease * Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study. * Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers * Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment Other inclusion and exclusion criteria as defined in the study protocol

Study sites (11)

CO

FL

MI

MO

NE

NY

TN

TX

VA