What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, have a range of side effects. Chemotherapy can cause neuropathy, diarrhea, nausea, vomiting, fatigue, and alopecia. Oxaliplatin-based chemotherapy specifically can lead to long-term neuropathy. Capecitabine is associated with hand-foot syndrome, diarrhea, nausea, vomiting, stomatitis, and fatigue. Immunotherapies like nivolumab and ipilimumab can cause immune-related adverse events, including diarrhea, infusion-related reactions, and fatigue. These side effects vary in severity and duration, impacting patients' quality of life during and after treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced solid tumors, including immunotherapies and targeted therapies. Notable immunotherapies include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and ipilimumab, which targets CTLA-4. These drugs have shown efficacy in treating various solid tumors such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Targeted therapies like bevacizumab, which inhibits angiogenesis, and tyrosine kinase inhibitors such as sunitinib and sorafenib, have also been approved for treating solid tumors, including renal cell carcinoma and hepatocellular carcinoma. These treatments have significantly advanced the management of solid tumors by offering more personalized and effective therapeutic options.

What other types of research exist?

Promising novel alternatives to SON-1010 for solid tumor patients include: 1) OS2966, a monoclonal antibody against β1 integrin, which inhibits proliferation and increases survival in high-grade meningioma models. 2) CInQ-03, an allosteric MEK inhibitor, which has shown efficacy in suppressing cancer growth in vitro and in vivo without skin toxicity. 3) Cabozantinib (XL184), an oral tyrosine kinase inhibitor, which has demonstrated activity in medullary thyroid cancer and may be applicable to other solid tumors.

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SON-1010 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Sonnet BioTherapeutics

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

Adequate organ and bone marrow function as defined by specific laboratory parameters

Must not have

Specific cardiac events within a defined timeframe

Use of biotin or supplements containing biotin above a certain daily intake

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing SON-1010, a new medicine for patients with advanced solid tumors. SON-1010 combines IL12 with an antibody part to stay in the body longer and work better. It attaches to albumin in the blood, making it safer and more effective.

Who is the study for?

Adults over 18 with advanced solid tumors who've tried standard treatments without success or can't receive them due to health issues. They must weigh between 50-120 kg, have a good performance status (able to carry out daily activities), and proper organ function. Women of childbearing age need a negative pregnancy test and must use two forms of birth control; men also need to use contraception.

What is being tested?

SON-1010 is being tested for safety, tolerability, and how it's processed by the body in adults with advanced solid tumors. This first-in-human study has an adaptive design where participants receive SON-1010 as an outpatient treatment.

What are the potential side effects?

As this is a Phase 1 trial primarily focused on safety and tolerability, specific side effects are not listed but may include typical reactions related to cancer therapies such as fatigue, nausea, allergic reactions or infusion-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood tests show my organs and bone marrow are working well.

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I am 18 years old or older.

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My cancer is confirmed by lab tests to be a solid tumor.

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I am not pregnant and agree to use two effective birth control methods during and 30 days after the study.

Exclusion Criteria

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

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I have not had any heart problems recently.

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I do not take high doses of biotin or biotin supplements.

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I have cancer that has spread to my brain or its coverings.

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I have HIV or a history of Kaposi sarcoma or Multicentric Castleman Disease.

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I have an active liver disease.

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I still have side effects from previous cancer treatments.

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I have had recent vaccinations or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To establish the maximum tolerated dose (MTD) of SON-1010

To establish the recommended Phase 2 dose (RP2D) of SON-1010

To evaluate the safety and tolerability of SON-1010

Secondary study objectives

Effect of SON-1010 on Serum cytokine levels

Evaluation of SON-1010 immunogenicity

Serum and urine concentrations of SON-1010 will be determined at various time points

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: RP2D ExpansionExperimental Treatment1 Intervention

RP2D Dose of SON-1010

Group II: Dose Level 5Experimental Treatment1 Intervention

SON-1010 Dose Level 5

Group III: Dose Level 4Experimental Treatment1 Intervention

SON-1010 Dose Level 4

Group IV: Dose Level 3Experimental Treatment1 Intervention

SON-1010 Dose Level 3

Group V: Dose Level 2Experimental Treatment1 Intervention

SON-1010 Dose Level 2

Group VI: Dose Level 1Experimental Treatment1 Intervention

SON-1010 Dose Level 1

0 / 12Eligibility 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 solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, often by inhibiting checkpoints that prevent immune activation. These mechanisms are crucial for solid tumor patients as they offer different strategies to control or eliminate tumors, potentially improving survival rates and quality of life while aiming to reduce adverse effects.

Current trends and future directions in the genetic therapy of human neoplastic disease.