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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
  • 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

Recruiting Locations

NEXT San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Jordan Georg
210-580-9521
jgeorg@nextoncology.com

NEXT Virginia
Fairfax 4758023, Virginia 6254928 22031
Contact:
Maybelle de la Rosa
703-783-4518
mdelarosa@nextoncology.com

More Details

NCT ID
NCT07312903
Status
Recruiting
Sponsor
Dewpoint Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center