A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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;
• Acceptable coagulation function;
⁃ Recovered from prior treatment Adverse Effect;
⁃ Effective contraception for female participant with child bearing potential participants and sexually active male participants.
Locations
United States
Arizona
Banner MD Anderson Cancer Center (BMDACC)
RECRUITING
Gilbert
Michigan
Henry Ford Health System
RECRUITING
Detroit
North Carolina
Carolina BioOncology Institute
RECRUITING
Huntersville
Oklahoma
Stephenson Cancer Center, University of Oklahoma
RECRUITING
Oklahoma City
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Jianjun Wang
wangjianjun@qurgen.com
+1（248）607 8451
Backup
Yingyi zhang
zhangyingyi@qurgen.com
+1-248-862-1598
Time Frame
Start Date:2023-09-19
Estimated Completion Date:2026-03
Participants
Target number of participants:150
Treatments
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.