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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
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
To establish the recommended Phase 2 dose (RP2D) of SON-1010
To evaluate the safety and tolerability of SON-1010
Secondary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
Sonnet BioTherapeuticsLead Sponsor
3 Previous Clinical Trials
206 Total Patients Enrolled
Richard Kenney, MDStudy DirectorSonnet BioTherapeutics
5 Previous Clinical Trials
277 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have not had any heart problems recently.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.I have another type of cancer, but it's under control.I do not take high doses of biotin or biotin supplements.I have cancer that has spread to my brain or its coverings.I am fully active or restricted in physically strenuous activity but can do light work.I have HIV or a history of Kaposi sarcoma or Multicentric Castleman Disease.I have not had immunotherapy or checkpoint inhibitors recently.I have an active liver disease.I still have side effects from previous cancer treatments.My cancer has spread beyond its original location.My blood tests show my organs and bone marrow are working well.I have had recent vaccinations or active infections.I have not taken steroids recently.I am 18 years old or older.My cancer is confirmed by lab tests to be a solid tumor.My cancer can be measured using specific criteria.I am not pregnant and agree to use two effective birth control methods during and 30 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level 4
- Group 3: Dose Level 3
- Group 4: Dose Level 5
- Group 5: Dose Level 2
- Group 6: RP2D Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you evaluate the potential risk posed by SON-1010 treatment?
"There is limited data available regarding SON-1010's safety and efficacy, thereby receiving a score of 1."
Answered by AI
Are there still opportunities to join this clinical investigation?
"According to the data accessible through clinicaltrials.gov, this medical trial is recruiting, with initial posting on April 20th 2022 and most recent revision on October 4th of that same year."
Answered by AI
How many individuals are actively participating in this experiment?
"Affirmative. The information on clinicaltrials.gov states that this medical trial, which was initially available for recruitment on April 20th 2022, is still looking for candidates to partake in the experiment. 36 patients need to be recruited from 1 location."
Answered by AI
What is the desired outcome of this research endeavor?
"This clinical trial's primary objective is to observe the safety and tolerability of SON-1010 over an average duration of one year. Secondary metrics evaluated include response rate per RECIST 1.1, serum cytokine levels (IL-2, IL-6, IL-10) from blood samples collected throughout the study period, and anti-SON-1010 antibody development."
Answered by AI
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