Your session is about to expire
← Back to Search
Checkpoint Inhibitor
SB 11285 + Atezolizumab for Advanced Solid Cancers
Phase 1
Recruiting
Research Sponsored by F-star Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential must meet postmenopausal or surgical sterilization criteria
An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks to 12 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what the best dose is and how well it works in people with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors, including melanoma and head/neck cancers, who've failed previous anti-PD-1/PD-L1 therapy. They must be in good physical condition (ECOG ≤1), have measurable disease, recovered from past treatments' toxicity, not pregnant or nursing, use effective birth control, and have proper organ function.Check my eligibility
What is being tested?
The trial is testing SB 11285 alone and combined with Atezolizumab in patients with advanced solid tumors. It's a Phase 1 study to find the safest dose that can be given without severe side effects (DLT) and to determine the recommended Phase 2 dose (RP2D).See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. Organ inflammation could occur due to immune system activation by these drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My cancer is advanced, cannot be surgically removed, and has worsened after treatment.
Select...
My cancer is in the mouth, throat, or voice box and does not respond to specific immune therapy.
Select...
I have advanced melanoma that didn't respond to anti-PD-1/L1 therapy, and if it's BRAF mutated, I've had BRAF/MEK therapy.
Select...
I am 18 years old or older.
Select...
I am a woman who can have children and my pregnancy test was negative.
Select...
I am 18 years old or older.
Select...
My cancer is advanced and hasn't responded to specific treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Determination of the MTD
Part 1: Determination of the RP2D
Part 1: Incidence of Adverse Events [Safety and Tolerability]
+4 moreSecondary outcome measures
Part 1 and 2: AUC (Plasma of SB 11285 )
Part 1 and 2: AUC (Plasma of SB 11312)
Part 1 and 2: Cmax (Plasma of SB 11285)
+8 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
5Treatment groups
Experimental Treatment
Group I: Part 2: Combination Expansion Cohorts at RP2D (Cohort C)Experimental Treatment2 Interventions
Cohort C: Patients with tumor types other then Cohort A and B (Naïve or relapsed refractory to anti PD-1/PD-L1)
After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Group II: Part 2: Combination Expansion Cohorts at RP2D (Cohort B)Experimental Treatment2 Interventions
Cohort B: Patients with HNSCC
After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Group III: Part 2: Combination Expansion Cohorts at RP2D (Cohort A)Experimental Treatment2 Interventions
Cohort A: Patients with Melanoma
After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Group IV: Part 1b: PD-L1 Combination Dose EscalationExperimental Treatment2 Interventions
SB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses plus 1680mg every 4 weeks (Q4W) atezolizumab
Group V: Part 1a: Monotherapy Dose EscalationExperimental Treatment1 Intervention
SB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
F-star Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
334 Total Patients Enrolled
invoX Pharma LimitedLead Sponsor
3 Previous Clinical Trials
549 Total Patients Enrolled
Louis KayitalireStudy DirectorChief Medical Officer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor believes you will live for at least three more months.I have a history or risk of heart problems.I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.You have an existing medical condition that is not being properly managed.I have an autoimmune disease treated with medication in the last 2 years.I am willing and able to sign a consent form.My blood counts and organ functions are within normal ranges.I do not have significant lung, kidney, liver, hormone, immune system, or muscle and skin conditions.My condition matches the disease characteristics for Part 1 of the study.I haven't had live vaccines in the last 4 weeks and don't plan to during or within 5 months after atezolizumab treatment.My cancer is not responding to PD-1/PD-L1 inhibitors.I am fully active and can carry on all pre-disease activities without restriction.My cancer is advanced, cannot be surgically removed, and has worsened after treatment.My cancer is in the mouth, throat, or voice box and does not respond to specific immune therapy.My cancer did not respond to previous immunotherapy treatments.I have advanced melanoma that didn't respond to anti-PD-1/L1 therapy, and if it's BRAF mutated, I've had BRAF/MEK therapy.I stopped immunotherapy because of its side effects.I am not taking medications that greatly affect my heart's rhythm.I am 18 years old or older.I have no side effects from past cancer treatments.I am a woman who can have children and my pregnancy test was negative.I had major surgery less than 4 weeks ago.I have not had recent radiation therapy.You have a medical condition that can be measured using a specific set of criteria called RECIST v1.1.I am currently on IV antibiotics for an infection.I have had serious lung inflammation.I am 18 years old or older.I am on long-term steroids or other drugs that weaken my immune system.I have recently been diagnosed with brain metastasis.I do not have any cancer other than the one being treated in this study.I have been treated with specific medications before.My cancer is advanced and hasn't responded to specific treatments.My condition and previous treatments qualify me for Part 2 of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Combination Expansion Cohorts at RP2D (Cohort B)
- Group 2: Part 1b: PD-L1 Combination Dose Escalation
- Group 3: Part 1a: Monotherapy Dose Escalation
- Group 4: Part 2: Combination Expansion Cohorts at RP2D (Cohort A)
- Group 5: Part 2: Combination Expansion Cohorts at RP2D (Cohort C)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Share this study with friends
Copy Link
Messenger