Recruiting
Phase 1

SON-DP

Sponsor:

Qurgen Inc.

Code:

NCT05989724

Conditions

Solid Tumor

Breast Cancer

Pancreatic Cancer

Ovarian Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SON-DP

Study Details

Brief 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.

Conditions

Solid Tumor

Breast Cancer

Pancreatic Cancer

Ovarian Cancer

Colorectal Cancer

Study ID

NCT05989724

Start date

Sep 19, 2023

Status verified date

Apr, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed written informed consent;
2. Male or female participants aged ≥ 18 years;
3. 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;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months;
5. Agree to the placement of drug infusion venous access;
6. For high dose group, agree for two biopsies, one at screening and one at 1st week of cycle 3;
7. Adequate hematological function;
8. Adequate hepatic/renal function;
9. Acceptable coagulation function;
10. Recovered from prior treatment Adverse Effect;
11. Effective contraception for female participant with child bearing potential participants and sexually active male participants.

Exclusion Criteria:

1. Participation in investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
2. Impaired cardiac function or clinically significant cardiac disease.
3. History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
4. Malignant disease, other than that being treated in this study.
5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to study entry.
6. Active infection requiring intravenous systemic antibiotic or antiviral therapy within 14 days prior to the first dose of study drug.
7. Major surgery within 4 weeks of the first dose of study treatment.
8. 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.
9. Active pneumonitis, the suspected pneumonitis that cannot be ruled out based on the imaging at Screening or based on the Investigator's judgement and a history of the (non-infectious) pneumonitis that required steroids within the past 12 months

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

SON-DP

Solution for IV administration

Primary outcome measure

  • 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. [ Time Frame: Up to 7 months after the first dose ]
  • MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II) [ Time Frame: During 28-day DLT observation period ]

Central Contacts and Locations

Locations

Banner MD Anderson Cancer Center (BMDACC)

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Jason Niu

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Amy Weise

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Principal Investigator:

John Powderly

Stephenson Cancer Center, University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Susanna Ulahannan

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Siqing Fu

More Information

Sponsor

Qurgen Inc.

Last update posted

Apr 24, 2024

Last verified

Apr, 2024

Keywords

  • SON-DP
  • Solid Tumor
  • Breast Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Colorectal cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Qurgen Inc. on 2024-04-24.