DPTX3186 in Wnt Pathway Activated Solid Tumors

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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

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