Your session is about to expire
← Back to Search
Monoclonal Antibodies
FS118 for Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by F-star Therapeutics Limited
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 ≤1
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of FS118, a new drug for treating advanced tumors. The trial will determine the maximum tolerated dose and assess how well the drug works.
Who is the study for?
Adults over 18 with advanced tumors, specifically squamous cell carcinoma of the head and neck (SCCHN), who've had no more than two systemic treatments for recurrent/metastatic SCCHN and one prior anti-PD-1 or anti-PD-L1 therapy. Participants must be able to undergo biopsies, have a life expectancy of at least three months, an ECOG status ≤1, use effective contraception, and provide consent.Check my eligibility
What is being tested?
FS118 is being tested both alone and in combination with paclitaxel to determine its safety, tolerability, optimal dosing levels (MTD/RP2D), pharmacokinetics (PK), efficacy against advanced tumors including SCCHN. This first-in-human study will also assess FS118's pharmacodynamics and immunogenicity.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs; infusion-related reactions; fatigue; digestive issues like nausea or diarrhea; blood disorders that could affect clotting or immunity; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
My last treatment was with anti-PD-1 or anti-PD-L1, after no more than 2 other treatments for my cancer.
Select...
My cancer has worsened despite treatment targeting PD-1/PD-L1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose escalation: Area under the serum FS118 concentration vs time Curve (AUC)
Dose escalation: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Dose escalation: Maximum Serum Concentration of FS118
+6 moreSecondary outcome measures
Dose escalation and expansion cohort of FS118 + paclitaxel
Dose escalation: Disease Response as assessed by RECIST 1.1 and iRECIST
Expansion cohort: Area under the serum FS118 concentration vs time Curve (AUC)
+6 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: FS118 weeklyExperimental Treatment2 Interventions
The initial cohorts will enroll sequentially as single-participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design followed by an expansion cohort of participants with SCCHN and an expansion SCCHN cohort in combination with Paclitaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
F-star Therapeutics LimitedLead Sponsor
2 Previous Clinical Trials
454 Total Patients Enrolled
invoX Pharma LimitedLead Sponsor
3 Previous Clinical Trials
600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to have biopsy procedures before and during treatment, and they are not considered high risk.My cancer originates in the nasopharynx or thyroid.I had severe side effects from previous immune therapy.I have never had severe lung issues, brain inflammation, seizures, or bad reactions to immune therapy.I am fully active or can carry out light work.My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.My cancer stopped responding to a specific immunotherapy.I have serious heart problems.I am 18 years old or older.I am at high risk for severe illness if I get COVID-19.I had COVID-19 but haven't shown a negative test result within the last 28 days.I have a known infection.I do not have uncontrolled brain metastases or tumors.My last treatment was with anti-PD-1 or anti-PD-L1, after no more than 2 other treatments for my cancer.I haven't had cancer treatment or a LAG-3 inhibitor within the last 28 days.I have an autoimmune disease.My cancer has worsened despite treatment targeting PD-1/PD-L1.I have a chronic illness that is not well-controlled.I've had one prior anti-PD-1 or PD-L1 therapy and my cancer has a PD-L1 score of 1% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: FS118 weekly
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.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger