SB 11285 for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas MD Anderson Cancer Center, Houston, TXHead and Neck Squamous Cell Carcinoma (HNSCC)+2 MoreSB 11285 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Solid Tumors
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

7 Primary · 11 Secondary · Reporting Duration: 8 weeks to 12 months

Month 12
Part 2: Preliminary antitumor activity of SB 11285 in combination with atezolizumab
Month 12
Part 2: Incidence of adverse events [Safety and Tolerability]
Month 12
Part 1 and 2: Duration of response (DOR)
Part 1 and 2: Progression-free survival (PFS)
Part 1: Incidence of Adverse Events [Safety and Tolerability]
Part 1: Objective response rate (ORR)
Part 2: Confirmation of recommended RP2D and schedule of SB 11285 in combination with atezolizumab
Month 12
Part 1: Determination of the RP2D
Cycle 1 (4 Weeks)
Part 1: Determination of the MTD
Cycle 1 (4 weeks)
Part 1: Observation of DLT
up to 12 months
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)
Part 1 and 2: Cmax (Plasma of SB 11312)
Part 1 and 2: Plasma of SB 11312
Part 1 and 2: Time to Cmax (Plasma of SB 11285 )
Part 1 and 2: Time to Cmax (Plasma of SB 11312)
up to 39 months
Part 1 and 2: Overall survival (OS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Side Effects for

Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Anaemia
12%Vomiting
11%Musculoskeletal pain
11%Rash
11%Back pain
10%Headache
9%Oedema peripheral
9%Insomnia
9%Weight decreased
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Myalgia
7%Haemoptysis
7%Upper respiratory tract infection
6%Alanine aminotransferase increased
6%Influenza like illness
6%Nasopharyngitis
6%Bronchitis
6%Productive cough
5%Depression
5%Dry skin
5%Musculoskeletal chest pain
4%Urinary tract infection
4%Abdominal pain
4%Paraesthesia
4%Neuropathy peripheral
3%Pneumonia
3%Stomatitis
3%Dysgeusia
2%Neutropenia
2%Pleural effusion
2%Malaise
1%Respiratory tract infection
1%Sepsis
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Pneumonitis
1%Lacrimation increased
1%Alopecia
1%Mucosal inflammation
1%Bone pain
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

5 Treatment Groups

Part 2: Combination Expansion Cohorts at RP2D (Cohort C)
1 of 5
Part 2: Combination Expansion Cohorts at RP2D (Cohort A)
1 of 5
Part 1b: PD-L1 Combination Dose Escalation
1 of 5
Part 2: Combination Expansion Cohorts at RP2D (Cohort B)
1 of 5
Part 1a: Monotherapy Dose Escalation
1 of 5

Experimental Treatment

146 Total Participants · 5 Treatment Groups

Primary Treatment: SB 11285 · No Placebo Group · Phase 1

Part 2: Combination Expansion Cohorts at RP2D (Cohort C)Experimental Group · 2 Interventions: SB 11285, Atezolizumab · Intervention Types: Drug, Drug
Part 2: Combination Expansion Cohorts at RP2D (Cohort A)Experimental Group · 2 Interventions: SB 11285, Atezolizumab · Intervention Types: Drug, Drug
Part 1b: PD-L1 Combination Dose EscalationExperimental Group · 2 Interventions: SB 11285, Atezolizumab · Intervention Types: Drug, Drug
Part 2: Combination Expansion Cohorts at RP2D (Cohort B)Experimental Group · 2 Interventions: SB 11285, Atezolizumab · Intervention Types: Drug, Drug
Part 1a: Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: SB 11285 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks to 12 months

Who is running the clinical trial?

F-star Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
334 Total Patients Enrolled
Naomi LaingStudy DirectorVice-President of Clinical Development
Louis KayitalireStudy DirectorChief Medical Officer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced or metastatic melanoma that has not responded to treatment with a specific type of antibody. If your melanoma has a specific mutation called BRAF, you must have already received a certain type of therapy for it.
You have cancer in the mouth, throat, or voice box that has come back after previous treatment with anti-PD-1/PD-L1 medication. However, if your cancer started in the nasal area, you are not eligible.
You are 18 years old or older, regardless of gender.
You have a solid tumor that has spread or cannot be removed with surgery. You have already tried treatments that are known to help, but they did not work or caused intolerable side effects.
You have advanced cancer that has come back or doesn't respond to standard treatments, including chemotherapy and anti-PD-1/PD-L1 antibody therapy.
You are able to perform daily activities without assistance or with minimal assistance.
You have a medical condition that can be measured using a specific set of criteria called RECIST v1.1.
The trial is primarily looking for patients whose cancer has not responded to treatment with anti PD-1/PD-L1 therapy. The types of cancer being studied include but are not limited to melanoma, head and neck cancer, kidney cancer, liver cancer, Merkel cell carcinoma, bladder cancer, lung cancer, stomach cancer, ovarian cancer, endometrial cancer, triple negative breast cancer, cervical cancer, and colorectal cancer.
You have a type of cancer that is not included in the other two groups and have not responded to previous treatment with anti PD-1/PD-L1 drugs.
Your doctor believes you will live for at least three more months.