A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
Solid Tumor, Breast Cancer, Pancreatic Cancer
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring SON-DP, Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal cancer
Eligibility Criteria
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 2; Adequate hematological function; Adequate hepatic/renal function; Acceptable coagulation function; Recovered from prior treatment Adverse Effect; Effective contraception for female participant with child bearing potential participants and sexually active male participants. 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. Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer) 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.
Sites / Locations
- Banner MD Anderson Cancer Center (BMDACC)
- Henry Ford Health System
- Carolina BioOncology InstituteRecruiting
- Stephenson Cancer Center, University of Oklahoma
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose escalation, Cohort 1
Dose escalation, Cohort 2
Dose escalation, Cohort 3
Dose escalation, Cohort 4
Dose escalation, Cohort 5
Dose escalation, Cohort 6
Dose escalation, Cohort 7
Dose escalation, Cohort 8
Dose escalation, Cohort 9
Dose escalation, Cohort 10
Dose escalation, Cohort 11
Dose expansion, Arm 1
Dose expansion, Arm 2
Dose expansion, Arm 3
Dose expansion, Arm 4
Drug: SON-DP 1 participant or 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 1 at dose level 1 once per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 1 participant or 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 2 at dose level 2 once per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 3 at dose level 3 once per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 4 at dose level 4 once per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 5 at dose level 3 twice per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 6 at dose level 4 twice per week in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 7 at dose level 5 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 8 at dose level 6 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.
Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 9 at dose level 7 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.
Drug: SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion at the RP2D-1 dose level using either once per week or twice per week (FINAL SCHEDULE), for up to 6 cycles.
Drug: SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level using either once per week or twice per week (FINAL SCHEDULE), for up to 6 cycles.
Drug: SON-DP Up to 18 participants with breast cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level using the Final Schedule, for up to 6 cycles.
Drug: SON-DP Up to 18 participants with pancreatic cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.
Drug: SON-DP Up to 18 participants with ovarian cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.
Drug: SON-DP Up to 18 participants with colorectal cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.