SON-DP for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Qurgen Inc.

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Cardiac disease, Stroke, Pneumonitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests SON-DP, a new treatment for patients with advanced or metastatic solid tumors who haven't responded to other treatments. SON-DP works by changing cancer cells back into normal cells, offering a new way to treat cancer.

Do I need to stop my current medications for the SON-DP trial?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you should not have had anticancer therapy within 5 half-lives or 2 weeks before starting the study. It's best to discuss your current medications with the study team.

Research Team

Britney Winterberger

Principal Investigator

Tigermed America LLC.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I agree to have two biopsies for the high dose group.

I have recovered from any serious side effects of previous treatments.

Exclusion 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 have cancer other than the one being treated in this study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ia Dose Escalation

Participants receive SON-DP through 90-minute IV infusion once or twice a week to determine the maximum tolerated dose and recommended phase II dose.

Up to 6 cycles of 28 days each

Weekly or bi-weekly visits for infusion

Phase Ib Dose Expansion

Participants with specific cancer types receive SON-DP at the recommended phase II dose level to evaluate safety, PK, PD, and anti-tumor activity.

Up to 6 cycles of 28 days each

Weekly or bi-weekly visits for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of secondary outcomes such as overall survival and progression-free survival.

Up to 12 months

Treatment Details

Interventions

• SON-DP (Virus Therapy)

Trial Overview 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).

Participant Groups

Group I: Dose expansion, Arm 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 9 Experimental Treatment 1 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 8 Experimental Treatment 1 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 7 Experimental Treatment 1 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 6 Experimental Treatment 1 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 5 Experimental Treatment 1 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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 11 Experimental Treatment 1 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 10 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Qurgen Inc.

Lead Sponsor

Trials

2

Recruited

250+