DPTX3186 in Wnt Pathway Activated Solid Tumors

NCT07312903 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DPTX3186-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

  1. 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 2. Outcome Measure: Incidence of Serious Adverse Events Measure Description: Number of subjects with serious adverse events (SAEs) Time Frame: up to 36 months

  Up to 36 Months

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Drug: DPTX3186

Interventions

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

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dewpoint Therapeutics: lead

Study Sites (2)

NEXT San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (2)