Recruiting
Phase 1

DPTX3186

Sponsor:

Dewpoint Therapeutics

Code:

NCT07312903

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DPTX3186

Study Details

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

Study ID

NCT07312903

Start date

Jan, 2026

Status verified date

Jan, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Interventions

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 measure

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

Central Contacts and Locations

Locations

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210-580-9521jgeorg@nextoncology.com

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle de la Rosa

703-783-4518mdelarosa@nextoncology.com

More Information

Sponsor

Dewpoint Therapeutics

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dewpoint Therapeutics on 2026-01-12.