Recruiting

Phase 1

Phase 2

ATX-295First-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

Sponsor:

Accent Therapeutics

Code:

NCT06799065

Conditions

Advanced Solid Tumors

Breast Cancer Recurrent

Ovarian Cancer

High-grade Serous Ovarian Carcinoma

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ATX-295

ATX-295 and bevacizumab (or biosimilar)

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Breast Cancer Recurrent

Ovarian Cancer

High-grade Serous Ovarian Carcinoma

Triple Negative Breast Cancer

Study ID

NCT06799065

Start date

Mar 21, 2025

Status verified date

Oct, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

218 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

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

experimental: Dose Expansion: Platinum-Resistant, or -Intolerant HGSOC

experimental: Dose Expansion: Previously treated sqNSCLC

experimental: Dose Expansion: Platinum-Resistant, or -Intolerant HGSOC and select tumors

Interventions

ATX-295

ATX-295 tablets will be taken orally

ATX-295 and bevacizumab (or biosimilar)

ATX-295 tablets will be taken orally in combination with bevacizumab (or biosimilar) administered via intravenous infusion

Primary outcome measure

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295 as a monotherapy and in combination with bevacizumab (or biosimilar) [ Time Frame: 12 months ]
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Priya Rajaratnam

(339) 970-7383 clinicaltrials@accenttx.com

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michael Ehrmann

720-848-0300 MICHAEL.EHRMANN@CUANSCHUTZ.EDU

Principal Investigator:

Marisa Moroney, MD

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Latisha Hall

941-377-9993

Principal Investigator:

Judy Wang, MD

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Davonna Felder

313-576-9014 felderd@karmanos.org

Principal Investigator:

Wasif Saif, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Lindsey Mayer

lindseymayer@wustl.edu

Principal Investigator:

Premal Thaker, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Christina Caldwell

405-271-8001 Christina-Caldwell@ouhsc.edu

Principal Investigator:

Kathleen Moore, MD

NYU Longone Health (Long Island)

Recruiting

Long Island City, New York, United States, 11501

Contacts

Jennifer Coffey

212-263-4432 Jennifer.Coffey@nyulangone.org

Principal Investigator:

Bhavana Pothuri, MD

NYU Longone Health (Manhattan)

Recruiting

Manhattan, New York, United States, 10012

Contacts

Jennifer Coffey

212-263-4432 Jennifer.Coffey@nyulangone.org

Principal Investigator:

Bhavana Pothuri, MD

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Latisha Hall

615-329-7640

Principal Investigator:

Deepak Bhamidipati, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Timothy Yap, MD, PhD

713-563-1784 tyap@mdanderson.org

Principal Investigator:

Timothy Yap, MD, PhD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210-580-5921 jgeorg@nextoncology.com

Principal Investigator:

Ildefonso Ismael Rodriguez Rivera, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518 mdelarosa@nextoncology.com

Principal Investigator:

Alexander Spira, MD, PhD, FACP

More Information

Sponsor

Accent Therapeutics

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

KIF
KIF18A
HGSOC
Platinum-resistant
Platinum-intolerant
Platinum-refractory
sqNSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Accent Therapeutics on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.