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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks after the first dose
Awards & highlights
Study Summary
This trial tests a new drug to treat cancer in those who don't respond to other therapies.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to standard treatments. Participants must have good blood, liver, and kidney function, no recent major surgery or active infections, and not be in other studies. They should be able to undergo biopsies and agree to use effective contraception.Check my eligibility
What is being tested?
SON-DP is being tested in this first-in-human study on patients with relapsed or intolerant solid tumors. The trial will assess the drug's safety, how it's processed by the body (pharmacokinetics), and its effects on tumor biology (pharmacodynamics).See study design
What are the potential side effects?
As SON-DP is a new treatment under investigation, potential side effects are being studied; however, common risks may include reactions at the infusion site, changes in blood counts or organ functions which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and my doctor thinks I have at least 3 months to live.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 weeks after the first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks after the first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
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.
Secondary outcome measures
AUC0-t
CL
Cmax
+8 moreOther outcome measures
SON-DP concentration in tumor biopsy tissue
Trial Design
15Treatment groups
Experimental Treatment
Group I: Dose expansion, Arm 4Experimental Treatment1 Intervention
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.
Group II: Dose expansion, Arm 3Experimental Treatment1 Intervention
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.
Group III: Dose expansion, Arm 2Experimental Treatment1 Intervention
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.
Group IV: Dose expansion, Arm 1Experimental Treatment1 Intervention
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.
Group V: Dose escalation, Cohort 9Experimental Treatment1 Intervention
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.
Group VI: Dose escalation, Cohort 8Experimental Treatment1 Intervention
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.
Group VII: Dose escalation, Cohort 7Experimental Treatment1 Intervention
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.
Group VIII: Dose escalation, Cohort 6Experimental Treatment1 Intervention
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.
Group IX: Dose escalation, Cohort 5Experimental Treatment1 Intervention
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.
Group X: Dose escalation, Cohort 4Experimental Treatment1 Intervention
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.
Group XI: Dose escalation, Cohort 3Experimental Treatment1 Intervention
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.
Group XII: Dose escalation, Cohort 2Experimental Treatment1 Intervention
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.
Group XIII: Dose escalation, Cohort 11Experimental Treatment1 Intervention
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.
Group XIV: Dose escalation, Cohort 10Experimental Treatment1 Intervention
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.
Group XV: Dose escalation, Cohort 1Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Qurgen Inc.Lead Sponsor
Britney WinterbergerStudy DirectorTigermed America LLC.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment within the last 2 weeks or 5 half-lives of the drug.I have not had major surgery in the last 4 weeks.I am 18 years old or older.I have cancer other than the one being treated in this study.I have heart problems that affect my daily activities.I have not had a stroke or significant bleeding in the brain in the last 6 months.I agree to have two biopsies for the high dose group.I have recovered from any serious side effects of previous treatments.I am using effective birth control methods.My blood counts are within a healthy range.My liver and kidneys are working well.My blood clotting function is normal.I have not needed IV antibiotics or antivirals in the last 14 days.I have a solid tumor diagnosis or specific cancer type (breast, pancreatic, ovarian, colorectal) for different trial phases.I am mostly active and my doctor thinks I have at least 3 months to live.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation, Cohort 11
- Group 2: Dose escalation, Cohort 7
- Group 3: Dose expansion, Arm 1
- Group 4: Dose expansion, Arm 2
- Group 5: Dose escalation, Cohort 10
- Group 6: Dose escalation, Cohort 6
- Group 7: Dose escalation, Cohort 8
- Group 8: Dose escalation, Cohort 9
- Group 9: Dose escalation, Cohort 5
- Group 10: Dose escalation, Cohort 1
- Group 11: Dose escalation, Cohort 2
- Group 12: Dose escalation, Cohort 3
- Group 13: Dose escalation, Cohort 4
- Group 14: Dose expansion, Arm 3
- Group 15: Dose expansion, Arm 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Dose escalation, Cohort 1 protocol been given authorization by the FDA?
"As this is an early stage clinical trial, the safety of Dose escalation in Cohort 1 was assigned a score of 1 due to lack of data related to efficacy and safety."
Answered by AI
Is enrollment for this medical experiment still available?
"Affirmative- clinicaltrials.gov asserts that this study is in the midst of patient recruitment. The trial was posted on August 1st 2023 and its details were most recently revised four days later."
Answered by AI
How many participants have enrolled in the research so far?
"To ensure the success of this experiment, 150 subjects who meet its eligibility standards must be recruited by Qurgen Inc., from two sites - Henry Ford Health System in Detroit and Carolina BioOncology Institute in Huntersville."
Answered by AI
In what geographic areas is this research trial being conducted?
"This study is taking place at the Henry Ford Health System in Detroit, Michigan; Carolina BioOncology Institute in Huntersville, North carolina; Stephenson Cancer Center, University of Oklahoma in Oklahoma City, Oklahoma and a further 5 medical sites."
Answered by AI
What aims are being pursued by this exploration?
"This study, which will run for a maximum of 7 months from the initial dose, strives to determine both Maximum tolerable dose (MTD) and Recommended dose for phase II (RP2D). Secondary metrics such as Disease control rate (DCR), Duration of response (DoR), and Time-to-event endpoints of time to disease progression (TTP) are also used."
Answered by AI
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