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Monoclonal Antibodies

FS120 for Cancer

Phase 1
Recruiting
Research Sponsored by invoX Pharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception
For monotherapy part: participants must have histologically confirmed, locally advanced, unresectable or metastatic solid tumors of specific types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, FS120, to see if it is safe and effective in treating people with advanced cancer.

Who is the study for?
Adults with advanced cancers eligible for pembrolizumab can join this trial. They must have measurable disease, be in good physical condition, and agree to biopsies. HIV-positive participants are allowed if they're healthy. Women must use effective contraception or not be of childbearing potential.Check my eligibility
What is being tested?
FS120, a new cancer drug targeting two immune system proteins (OX40/CD137), is being tested alone and alongside Pembrolizumab to see its safety and effectiveness against various advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's enhancement which may affect organs, cause fatigue or flu-like symptoms. Specific side effects will depend on how FS120 interacts with the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant, breastfeeding, and if able to bear children, I use effective birth control.
Select...
My cancer is advanced, cannot be surgically removed, and is of a specific type.
Select...
I am 18 years old or older.
Select...
I agree to have a biopsy before and during treatment.
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My cancer is advanced, cannot be surgically removed, and pembrolizumab is approved for my condition.
Select...
I have HIV but am in good health with a low risk of developing AIDS.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: FS120Experimental Treatment1 Intervention
Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts

Find a Location

Who is running the clinical trial?

invoX Pharma LimitedLead Sponsor
3 Previous Clinical Trials
418 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,711 Total Patients Enrolled
F-star Therapeutics LimitedLead Sponsor
2 Previous Clinical Trials
272 Total Patients Enrolled

Media Library

FS120 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04648202 — Phase 1
Cancer Research Study Groups: FS120
Cancer Clinical Trial 2023: FS120 Highlights & Side Effects. Trial Name: NCT04648202 — Phase 1
FS120 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648202 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of individuals permitted to join this clinical trial?

"Absolutely, the published information on clinicaltrials.gov attests to this trial's ongoing recruitment process which commenced in November 2020 and was last updated in August of 2022. There is need for 277 volunteers across three locations."

Answered by AI

Are there currently any vacancies for participants of this clinical trial?

"Indeed, the information posted on clinicaltrials.gov confirms that this study is still open for recruitment. It was initially listed on November 18th 2020 and most recently updated in August 8th 2022. The researchers are aiming to acquire 277 patients from 3 different sites."

Answered by AI

Has the FS120 medication been given clearance by the FDA?

"FS120 is currently being assessed in a Phase 1 trial, thus the safety rating for this medication was registered as a score of 1 due to scant evidence indicating its efficacy and security."

Answered by AI
~101 spots leftby Mar 2026