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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Richard Kenney, MD

Principal Investigator

Sonnet BioTherapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+