DPTX3186 for Wnt-pathway activated solid tumors
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
PHASE1 · Dewpoint Therapeutics · NCT07312903
This first-in-human study will try an oral drug called DPTX3186 in adults whose solid tumors are driven by the Wnt pathway and who have no approved treatment options left.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dewpoint Therapeutics (industry) |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT07312903 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, first-in-human trial of DPTX3186 given to adults with solid tumors known to have Wnt-pathway activation. The study will escalate doses to define safety and pharmacokinetics, record any early signs of anti-tumor activity, and collect samples to explore pharmacodynamic biomarkers. Eligible patients must have measurable disease, good performance status (ECOG 0–1), and limited remaining standard treatment options. The drug is administered orally and participants will be seen at specialized clinical research sites for dosing and monitoring.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically or cytologically confirmed solid tumors known to be Wnt-pathway activated (for example colorectal, gastric, certain lung cancers, or triple-negative breast cancer), at least one measurable lesion, ECOG 0–1, life expectancy ≥3 months, and no approved treatment options available are the intended candidates.
Not a fit: Patients with symptomatic or uncontrolled brain metastases requiring treatment, another progressing malignancy needing therapy, inadequate organ function, known hypersensitivity to the drug, or conditions that prevent reliable oral drug absorption are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, DPTX3186 could provide a new targeted oral treatment option for patients with Wnt-activated cancers who currently lack approved therapies.
How similar studies have performed: Wnt-pathway targeting is an active but challenging area with few proven therapies so far, making this approach relatively novel with limited prior clinical success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas and 1 other locations
- NEXT San Antonio — San Antonio, Texas, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumors