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NCT Number: NCT07312903

DPTX3186 in Wnt Pathway Activated Solid Tumors

This is a first-in human clinical study of DPTX3186 in subjects with Wnt-pathway activated solid tumors where no other treatments exist. The study will evaluate safety, pharmacokinetics, and initial activity of DPTX3186, as well as explore pharmacodynamic parameters to identify potential biomarkers of efficacy

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NEXT San Antonio, San Antonio, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed solid tumor and tumor types known to be Wnt-pathway activated (such as colorectal cancer, gastric cancer, lung cancer, and triple negative breast cancer) and no other approved treatment options available.
  • At least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.
  • ECOG performance status of 0 or 1.
  • Physiological conditions that may prevent absorption of an oral medication including but not limited to colostomy and ileostomy.
  • Age ≥18 years (or ≥ age of majority per local regulation)
  • Life expectancy ≥3 months
  • Willing and able to comply with protocol requirements

Exclusion criteria

  • Symptomatic or uncontrolled brain metastasis requiring concurrent treatment,
  • Another known malignancy that is progressing or requires active treatment within the last 2 years (except basal cell carcinoma, in situ cervical cancer, etc.).
  • Inadequate organ function
  • Known hypersensitivity to study drug or excipients

Treatment and study plan

DPTX3186

Drug

Once daily (single dose of study drug in the morning in fasted conditions) for 4 consecutive days (4 days on) and 3 days off in a cycle of 28 days

Primary outcomes

  1. Incidence of treatment emergent adverse events and serious adverse events.

    Time frame: Up to 36 Months

    • Outcome Measure: Incidence of Treatment Emergent Adverse-Events Measure Description: Number of subjects with treatment-emergent adverse events (TEAEs) Time Frame: up to 36 months
    • Outcome Measure: Incidence of Serious Adverse Events Measure Description: Number of subjects with serious adverse events (SAEs) Time Frame: up to 36 months

Sponsors and collaborators

Lead sponsor

Dewpoint Therapeutics

Industry

Registry information

Official study title

An Open Label, Multicenter Study of DPTX3186 to Evaluate Safety, Tolerability, and Pharmacokinetics in Subjects With Known Wnt Pathway Activated Solid Tumors Where No Other Treatments Exist

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 31, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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