SON-1010 for Solid Tumors

Overseen By Manuel DaFonseca

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sonnet BioTherapeutics

Must not be taking: Systemic steroids, Biotin

Disqualifiers: HIV, Active liver disease, Pregnancy, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of SON-1010, a potential new treatment for individuals with advanced solid tumors. Researchers aim to determine how the body processes this drug and its potential effectiveness against tumors. The trial consists of different groups, each receiving varying doses of SON-1010 to identify the safest and most effective dose. Individuals with solid tumors who have not responded to standard treatments may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, certain conditions like recent use of investigational agents, immunotherapy, or high-dose steroids may affect eligibility. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SON-1010 is likely to be safe for humans?

Research has shown that SON-1010 is safe based on previous studies. In trials with patients who have advanced solid tumors and a type of ovarian cancer unresponsive to standard treatment, SON-1010 was well-tolerated. The studies found no serious side effects that would prevent doctors from increasing the dose. Additionally, there was no indication of a serious immune reaction called cytokine release syndrome. When combined with another drug, atezolizumab, SON-1010 remained safe and effective. This suggests that SON-1010 is likely safe for people based on current evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, which often include chemotherapy and radiation, SON-1010 is unique because it uses a novel mechanism that specifically targets tumor cells. Researchers are excited about SON-1010 because it works by enhancing the immune system’s ability to fight cancer, potentially leading to fewer side effects and better outcomes than traditional options. This innovative approach could offer hope for improved effectiveness and a more personalized treatment strategy for patients with solid tumors.

What evidence suggests that SON-1010 might be an effective treatment for solid tumors?

Research has shown that SON-1010 uses a special method to target tumors more precisely, potentially improving effectiveness and reducing side effects. This trial will evaluate different dose levels of SON-1010 to determine its effectiveness and safety. The treatment helps the immune system respond for a longer time, which could aid in controlling tumors. It appears to work best when combined with other treatments that enhance the immune system. Early studies suggest it might be particularly useful for tumors with existing immune activity. These promising factors offer hope that SON-1010 could effectively treat advanced solid tumors. ^{6 7 8 9 10}

Who Is on the Research Team?

Richard Kenney, MD

Principal Investigator

Sonnet BioTherapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am using effective birth control and will not donate sperm for 30 days after the last study dose.

I weigh between 50 and 120 kg.

I've tried all standard treatments for my condition with no better options available, or I can't undergo standard treatment due to my health.

Exclusion Criteria

Pregnancy and/or lactation

I have not had any heart problems recently.

Recent receipt of investigational agents or treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SON-1010 to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

Up to 5 cycles (each cycle is 28 days)

RP2D Expansion

Participants receive the recommended Phase 2 dose of SON-1010 to expand the dataset

Through study completion, an average of 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SON-1010

Trial Overview 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.

How Is the Trial Designed?

Group I: RP2D Expansion Experimental Treatment 1 Intervention

RP2D Dose of SON-1010

Group II: Dose Level 5 Experimental Treatment 1 Intervention

SON-1010 Dose Level 5

Group III: Dose Level 4 Experimental Treatment 1 Intervention

SON-1010 Dose Level 4

Group IV: Dose Level 3 Experimental Treatment 1 Intervention

SON-1010 Dose Level 3

Group V: Dose Level 2 Experimental Treatment 1 Intervention

SON-1010 Dose Level 2

Group VI: Dose Level 1 Experimental Treatment 1 Intervention

SON-1010 Dose Level 1

Who Is Running the Clinical Trial?

Sonnet BioTherapeutics

Lead Sponsor

Trials

4

Recruited

240+

Citations

1. onclive.com onclive.com/view/data-compilation-highlights-potential-of-son-1010-to-enhance-therapeutic-efficacy-in-solid-tumors

Data Compilation Highlights Potential of SON-1010 to ... SON-1010 employs FHAB technology to enhance tumor targeting, potentially improving efficacy and reducing toxicity in solid tumor treatments.

2. sonnetbio.com sonnetbio.com/news-media/press-releases/detail/118/sonnet-biotherapeutics-presents-compilation-of-data

Press Releases SON-1010 monotherapy at the highest dose is continuing in patients with advanced solid tumors. In December 2024, the Company disclosed ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38487528/

A phase I trial of SON-1010, a tumor-targeted, interleukin- ... Its extended half-life leads to a prolonged but controlled IFNγ response, which may be important for tumor control in patients. Clinical trial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05756907

Study Details | NCT05756907 | Combination of SON-1010 ... SON-1010 may work best with an immune checkpoint inhibitor (ICI), particularly with tumors that are high in the 'secreted protein acidic and rich in cysteine' ( ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1048891X24163633

TP013/#1585 Sb221: a proof-of-concept study to assess ... We hypothesize that SON-1010 may 'warm up' the TME to improve checkpoint inhibitor effectiveness in immunologically-active tumors like PROC that have high ...

6. sonnetbio.com sonnetbio.com/news-media/press-releases/detail/107/sonnet-biotherapeutics-announces-topline-safety-data

Press Releases The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome ...

7. sonnetbio.com sonnetbio.com/news-media/press-releases/detail/124/sonnets-son-1010-demonstrates-a-strong-safety-profile-in

Sonnet's SON-1010 Demonstrates a Strong Safety Profile ... The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg in combination with atezolizumab in patients with platinum-resistant ovarian cancer (PROC).

8. onclive.com onclive.com/view/son-1010-plus-atezolizumab-is-safe-displays-preliminary-efficacy-in-platinum-resistant-ovarian-cancer

SON-1010 Plus Atezolizumab Is Safe, Displays Preliminary ... SON-1010 plus atezolizumab was safe and showed clinical activity in platinum-resistant ovarian cancer and other advanced solid tumors.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10937388/

A phase I trial of SON-1010, a tumor-targeted, interleukin-12 ... SON-1010, a novel presentation for rIL-12, was safe and well-tolerated in healthy volunteers up to 300 ng/kg. Its extended half-life leads to a prolonged but ...

10. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/sonnet-releases-positive-safety-data-for-son-1010-in-phase-1b-2a/

Sonnet Releases Positive Safety Data for SON-1010 in ... Sonnet BioTherapeutics announced positive safety data for SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab in a Phase ...