SON-DP for Advanced Cancer

Recruiting at 4 trial locations

Overseen By Yingyi zhang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Qurgen Inc.

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Cardiac disease, Stroke, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SON-DP for individuals with advanced or metastatic solid tumors that haven't responded to standard therapies. The trial aims to determine the safety and efficacy of SON-DP. Participants are divided into groups to receive different doses of SON-DP to identify the optimal amount. Individuals with breast, pancreatic, ovarian, or colorectal cancer, who have tried other treatments without success, might be suitable for this trial. Participants will receive SON-DP through an IV infusion and must be comfortable with regular administration. As a Phase 1 trial, this research focuses on understanding how SON-DP works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that SON-DP is likely to be safe for humans?

Research shows that SON-DP remains in the early stages of human testing, so limited information exists about its safety. In animal studies, SON-DP eliminated late-stage cancers without causing major problems, which is promising. However, as this is a Phase 1 trial, it marks the first time SON-DP is administered to people. This phase primarily focuses on assessing the treatment's safety and tolerability in humans. Solid data on human reactions is not yet available, highlighting the importance of these trials. Participants in early trials help researchers identify potential side effects and their severity. While early results are hopeful, the human trial will provide more concrete safety evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for advanced cancer?

Researchers are excited about SON-DP because it offers a novel approach to treating advanced cancers, including pancreatic, breast, ovarian, and colorectal cancers. Unlike many existing treatments, SON-DP is delivered through a 90-minute intravenous infusion, which allows for precise dosing and potentially improved patient outcomes. Its unique mechanism of action targets cancer cells more directly, which might lead to fewer side effects compared to traditional chemotherapy regimens. This innovative strategy could provide a new hope for patients with hard-to-treat tumors, making it a promising candidate in the fight against cancer.

What evidence suggests that this trial's treatment, SON-DP, could be effective for advanced cancer?

Research has shown that SON-DP is being explored as a potential treatment for advanced solid tumors, including pancreatic, breast, ovarian, and colorectal cancers. In this trial, participants will receive SON-DP in different treatment arms. Early studies suggest that SON-DP targets and alters cancer cells, potentially making it effective against various solid tumors. SON-DP is considered a unique treatment, showing promise in early lab research. Although human studies provide limited information, SON-DP is designed to target different types of solid tumors, offering hope for cancers unresponsive to traditional treatments. ^{1 3 5 6 7}

Who Is on the Research Team?

Britney Winterberger

Principal Investigator

Tigermed America LLC.

Are You a Good Fit for This Trial?

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 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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SON-DP

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).

How Is the Trial Designed?

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+

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-08586

A First-in-Human Study of SON-DP in Participants With ... 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, ...

2. careacross.com careacross.com/clinical-trials/trial/NCT05989724

A First-in-Human Study of SON-DP in Participants With ... - During Phase Ib dose expansion stage, SON-DP will be used, at RP2D dose level, to treat the participants with 4 specific cancer types including breast cancer, ...

3. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384977

ANZCTR - Registration SON-DP is proposed as an effective universal therapeutic drug for solid tumour cell-converting cancer therapy. The first-in-human (FIH) and first-in-class ...

4. withpower.com withpower.com/trial/phase-1-colorectal-neoplasms-7-2023-c09ee

SON-DP for Advanced Cancer This trial tests SON-DP, a new treatment for patients with advanced or metastatic solid tumors who haven't responded to other treatments.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02564900

NCT02564900 | Study of DS-8201a in Subjects With ... This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06873659?cond=liver&aggFilters=status%3A%2Cphase%3A

Study Details | NCT06873659 | SON-DP in Participants ... Preclinical studies demonstrated that treatment of tumors with SON-DP resulted in eradication of late-stage cancers and long term (over 3 years) survival ...

7. clinicaltrials.gastriccancer.org clinicaltrials.gastriccancer.org/en-US/trial/listing/416735

A First-in-Human Study of SON-DP in Participants With ... 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, ...