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Recruiting NCT07312903

DPTX3186 in Wnt Pathway Activated Solid Tumors

Phase I Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DPTX3186.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

Interventions

  • Drug DPTX3186
    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 outcome measures

  • Incidence of treatment emergent adverse events and serious adverse events. [Time frame: Up to 36 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • NEXT San Antonio — San Antonio
  • NEXT Virginia — Fairfax

Identifiers

NCT: NCT07312903 · DPTX3186-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗