Advanced Solid Tumors study: ATX-295 vs ATX-295 and bevacizumab
Official title 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
ClinicalTrials.gov ID: NCT06799065
What this study is testing
What is ATX-295?
ATX-295 is an investigational medicine, taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Sarasota, Florida, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Long Island City, New York, United States
- Manhattan, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Sarasota, Florida, United States; Detroit, Michigan, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; Long Island City, New York, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.