A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors

A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
Experimental: Dose escalation, Cohort 1

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

Solution for IV administration

Experimental: Dose escalation, Cohort 2

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

Solution for IV administration

Experimental: Dose escalation, Cohort 3

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

Solution for IV administration

Experimental: Dose escalation, Cohort 4

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

Solution for IV administration

Experimental: Dose escalation, Cohort 5

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

Solution for IV administration

Experimental: Dose escalation, Cohort 6

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

Solution for IV administration

Experimental: Dose escalation, Cohort 7

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

Solution for IV administration

Experimental: Dose escalation, Cohort 8

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

Solution for IV administration

Experimental: Dose escalation, Cohort 9

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

Solution for IV administration

Experimental: Dose escalation, Cohort 10

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

Solution for IV administration

Experimental: Dose escalation, Cohort 11

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

Solution for IV administration

Experimental: Dose expansion, Arm 1

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

Solution for IV administration

Experimental: Dose expansion, Arm 2

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

Solution for IV administration

Experimental: Dose expansion, Arm 3

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

Solution for IV administration

Experimental: Dose expansion, Arm 4

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.

Drug: SON-DP

Solution for IV administration

Source: View full study details on ClinicalTrials.gov

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August 15, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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