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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

ConditionsAdvanced Solid TumorsBreast Cancer RecurrentOvarian CancerHigh-grade Serous Ovarian CarcinomaTriple Negative Breast CancersqNSCLCSquamous Non-small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAccent Therapeutics

About 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ATX-295

    Drug

    ATX-295 tablets will be taken orally

  • ATX-295 and bevacizumab (or biosimilar)

    Drug

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

Treatment groups

218 Participants
are divided into 4 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose Expansion: Platinum-Resistant, or -Intolerant HGSOCExperimental treatment 1 intervention
Group C: Dose Expansion: Previously treated sqNSCLCExperimental treatment 1 intervention
Group D: Dose Expansion: Platinum-Resistant, or -Intolerant HGSOC and select tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295 as a monotherapy and in combination with bevacizumab (or biosimilar)

Identification of a tolerable and safe dose for expansion cohorts based on dose limiting toxicities

Time frame
12 months
2

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Adverse events graded according to CTCAE v5.0

Time frame
12 months

Secondary outcomes

1

Preliminary evidence of antitumor activity toxicities as a monotherapy and in combination with bevacizumab (or biosimilar)

Objective response rate based on RECIST v1.1

Time frame
12 months
2

Measurement of phospho-histone H3 in pre- and post-treatment biopsies for a subset of participants (pharmacodynamic biomarker)

Time frame
12 months
3

Maximum observed plasma concentration of ATX-295 (Cmax)

Time frame
12 months
4

Calculated time to reach maximum observed plasma concentration (Tmax)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Accent Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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