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
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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