A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard … (NCT05989724) | Clinical Trial Compass
UnknownPhase 1
A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
United States150 participantsStarted 2023-09-19
Plain-language summary
This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent;
✓. Male or female participants aged ≥ 18 years;
✓. For Phase Ia: Participants with histologic diagnosis and confirmed solid tumor; For Phase Ib: Participants with one of the four tumor types: breast cancer, pancreatic cancer, ovarian cancer or colorectal cancer;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months;
✓. Agree to the placement of drug infusion venous access;
✓. For high dose group, agree for two biopsies, one at screening and one at 1st week of cycle 3;
✓. Adequate hematological function;
✓. Adequate hepatic/renal function;
Exclusion criteria
✕. Participation in investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
✕. Impaired cardiac function or clinically significant cardiac disease.
✕. History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
✕. Malignant disease, other than that being treated in this study.
What they're measuring
1
Number of participants with AEs, with abnormal vital signs, abnormal ECG readings, abnormal clinical laboratory tests results, abnormal physical examinations and abnormal ECOG performance status.
. Anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to study entry.
✕. Active infection requiring intravenous systemic antibiotic or antiviral therapy within 14 days prior to the first dose of study drug.
✕. Major surgery within 4 weeks of the first dose of study treatment.
✕. Any medical condition that would, in the Investigator's judgment, prevent the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.