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Checkpoint Inhibitor

SB 11285 + Atezolizumab for Advanced Solid Cancers

Phase 1

Waitlist Available

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

Must not have

History or evidence of cardiovascular (CV) risk

Has an active autoimmune disease that has required systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks to 12 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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).

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 below

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I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer is advanced, cannot be surgically removed, and has worsened after treatment.

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My cancer is in the mouth, throat, or voice box and does not respond to specific immune therapy.

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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.

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I am 18 years old or older.

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I am a woman who can have children and my pregnancy test was negative.

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I am 18 years old or older.

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My cancer is advanced and hasn't responded to specific treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history or risk of heart problems.

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I have an autoimmune disease treated with medication in the last 2 years.

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I haven't had live vaccines in the last 4 weeks and don't plan to during or within 5 months after atezolizumab treatment.

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I stopped immunotherapy because of its side effects.

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I am not taking medications that greatly affect my heart's rhythm.

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I have not had recent radiation therapy.

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I am currently on IV antibiotics for an infection.

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I have had serious lung inflammation.

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I am on long-term steroids or other drugs that weaken my immune system.

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I have recently been diagnosed with brain metastasis.

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I do not have any cancer other than the one being treated in this study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Determination of the MTD

Part 1: Determination of the RP2D

Part 1: Incidence of Adverse Events [Safety and Tolerability]

+4 more

Secondary study objectives

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 more

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Pneumonia

Febrile neutropenia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

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.

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

0 / 20Eligibility criteria met