What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as carboplatin, pegylated liposomal doxorubicin (PLD), and paclitaxel, have distinct side effect profiles. Carboplatin can cause myelosuppression, leading to low blood cell counts, and hypersensitivity reactions. PLD is associated with hand-foot syndrome, mucositis, and less myelosuppression compared to other chemotherapies. Paclitaxel often results in neuropathy, alopecia, and myelosuppression. These side effects are important considerations for patients undergoing treatment for advanced or metastatic ovarian cancer.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of ovarian cancer, focusing on safety, tolerability, PK, and PD. Bevacizumab, an angiogenesis inhibitor, has been approved for use in combination with chemotherapy for platinum-sensitive recurrent ovarian cancer. Olaparib and niraparib, both PARP inhibitors, have been approved for maintenance treatment in patients with recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy. Additionally, pegylated liposomal doxorubicin and topotecan have been approved for the treatment of platinum-resistant ovarian cancer. These treatments emphasize the importance of targeting specific pathways and ensuring manageable safety profiles, similar to the goals of the SON-DP trial.

What other types of research exist?

Promising novel alternatives to SON-DP for ovarian cancer patients include: 1) PARP inhibitors such as olaparib, especially for patients with BRCA mutations or homologous recombination deficiency (HRD). 2) Angiogenesis inhibitors like bevacizumab, used in combination with platinum-based chemotherapy and as maintenance therapy. 3) Immunotherapy agents like pembrolizumab for patients with specific genetic markers such as dMMR or high TMB. These treatments have shown efficacy in clinical trials and are considered viable options for advanced or metastatic ovarian cancer.

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Virus Therapy

SON-DP for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Qurgen Inc.

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

Must not have

Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer) prior to study entry

Major surgery within 4 weeks of the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after the first dose

Awards & highlights

Summary

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.

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.

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).

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 below

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I am mostly active and my doctor thinks I have at least 3 months to live.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment within the last 2 weeks or 5 half-lives of the drug.

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I have not had major surgery in the last 4 weeks.

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

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I have heart problems that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after the first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after the first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after the first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

AUC0-t

Cmax

+8 more

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include platinum-based chemotherapies (e.g., carboplatin and cisplatin), PARP inhibitors (e.g., olaparib, niraparib), and angiogenesis inhibitors (e.g., bevacizumab). Platinum-based chemotherapies work by causing DNA cross-linking, which prevents cancer cells from replicating. PARP inhibitors block the PARP enzyme, leading to the accumulation of DNA damage in cancer cells, particularly effective in those with BRCA mutations. Angiogenesis inhibitors prevent the formation of new blood vessels that tumors need to grow. These mechanisms are crucial as they target the cancer cells' ability to repair and sustain themselves, offering hope for improved outcomes in advanced/metastatic cases, similar to the goals of the SON-DP trial which aims to evaluate new treatment options for patients with limited responses to standard therapies.

Emerging role of topotecan in front-line treatment of carcinoma of the ovary.