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ATX-295

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 18, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

ATX-295 · 1 trial · 5 indications

Phase 1 1
NCT06799065First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian CancerAdvanced Solid Tumors
RECRUITING90 Analytics
PHASE1RECRUITING
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of ATX-295
12 months

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

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

Adverse events graded according to CTCAE v5.0

Secondary Endpoints

Preliminary evidence of antitumor activity
12 months
Measurement of phospho-histone H3 in pre- and post-treatment biopsies for a subset of participants (pharmacodynamic biomarker)
12 months
Maximum observed plasma concentration of ATX-295 (Cmax)
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALSubjects will be enrolled at various doses and/or schedules of ATX-295 to identify the expansion dose(s) and RP2D
Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOCEXPERIMENTAL -

Interventions

NameTypeDescription
ATX-295DRUGATX-295 Tablets will be taken orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")