Solid Tumors
Conditions
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
Interventions
DRUGDPTX3186
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
Sponsors
Dewpoint Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events and serious adverse events. | Up to 36 Months | 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 |
Countries
United States
Outcome results
None listed