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Cytokine Therapy

SON-1010 + Atezolizumab for Ovarian Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Sonnet BioTherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years at the time of informed consent

Adequate organ and bone marrow function, in the absence of growth factors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test a new drug to see if it is safe and effective for advanced solid tumors and platinum-resistant ovarian cancer.

Who is the study for?

This trial is for adults over 18 with Platinum-resistant Ovarian Cancer (PROC) who've tried standard treatments without success. They must have an ECOG performance status ≤1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. Participants need proper organ and bone marrow function, no severe allergies to study drugs, not pregnant or breastfeeding, willing to use effective birth control, and able to consent.Check my eligibility

What is being tested?

The trial is testing SON-1010 combined with Atezolizumab in patients with advanced solid tumors (Part 1) and specifically those with PROC (Part 2). It's an open-label study meaning everyone knows what treatment they're getting. The goal is to assess safety, how well the body tolerates it, and how the drug moves through and affects the body.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to drug components; however specific side effects of SON-1010 aren't listed as this is early in its testing phase. Atezolizumab can cause immune-related issues like inflammation in organs, infusion reactions similar to allergic responses during administration of the drug, fatigue, digestive problems among others.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My organs and bone marrow are working well without any medical help.

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My cancer is advanced or has spread, confirmed by lab tests.

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I am fully active or have some restrictions but can still care for myself.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To establish the maximum tolerated dose (MTD) of SON-1010 in combination with Atezolizumab

To evaluate the safety and tolerability of SON-1010 in combination with Atezolizumab

Secondary outcome measures

To assess the anti-tumor activity of SON-1010 dosed with atezolizumab in Platinum-resistant Ovarian Cancer (PROC), compared with SON-1010 alone or SOC therapy

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

9Treatment groups

Experimental Treatment

Active Control

Group I: Randomized Arm #2 in Patients with Platinum-resistant Ovarian CancerExperimental Treatment1 Intervention

SON-1010 @ RP2D + Atezolizumab

Group II: Randomized Arm #1 in Patients with Platinum-resistant Ovarian CancerExperimental Treatment1 Intervention

SON-1010 @ RP2D Alone

Group III: RP2D Expansion in Patients with Platinum-resistant Ovarian CancerExperimental Treatment1 Intervention

RP2D Dose of SON-1010 + Atezolizumab

Group IV: Dose Level 5Experimental Treatment1 Intervention

SON-1010 Dose Level 5 + Atezolizumab

Group V: Dose Level 4Experimental Treatment1 Intervention

SON-1010 Dose Level 4 + Atezolizumab

Group VI: Dose Level 3Experimental Treatment1 Intervention

SON-1010 Dose Level 3 + Atezolizumab

Group VII: Dose Level 2Experimental Treatment1 Intervention

SON-1010 Dose Level 2 + Atezolizumab

Group VIII: Dose Level 1Experimental Treatment1 Intervention

SON-1010 Dose Level 1 + Atezolizumab

Group IX: Randomized Arm #3 in Patients with Platinum-resistant Ovarian CancerActive Control1 Intervention

Standard of Care

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sonnet BioTherapeuticsLead Sponsor

3 Previous Clinical Trials

77 Total Patients Enrolled

Hoffmann-La RocheIndustry Sponsor

2,432 Previous Clinical Trials

1,089,996 Total Patients Enrolled

16 Trials studying Ovarian Cancer

5,602 Patients Enrolled for Ovarian Cancer

Richard T Kenney, MDStudy DirectorSonnet BioTherapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this experiment?

"Affirmative. According to clinicaltrials.gov, the study is still searching for participants and was published on September 15th 2023 before its last update five days later. 165 people are needed at two distinct centres of care."

Answered by AI

Is the recruitment stage of this experiment still underway?

"Affirmative. According to clinicaltrials.gov data, this medical trial is actively seeking recruits since September 15th 2023 and was updated most recently on the twentieth of that same month. A total of 165 patients between two distinct sites must be enrolled in order for the study's objectives to be met."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

2023. "Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05756907.