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Advanced CancerPhase 1/2NCT03440437

A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies

A Phase 1/2 study testing FS118 and Paclitaxel in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FS118 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
12 sitesin 2 countries
Study dates
16 Apr 2018to 21 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants:
  • Age ≥18 years;
  • Participants with histologically confirmed, locally advanced, unresectable, or metastatic solid tumors that progressed while on or after PD-1/PD-L1 containing therapy;
  • Measurable disease;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;
  • Life expectancy estimated to be at least 3 months;
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  • Highly effective contraception;
  • Willing and able to provide written informed consent.
  • Expansion cohort only:
  • Histologically and/or cytologically confirmed recurrent/metastatic (R/M) SCCHN that is not amenable to curative therapy by surgery or radiation;
  • Only 1 prior anti-PD-1 or anti-PD-L1 therapy and documented PD-L1 scoring ≥1% by combined positive score or tumor proportion score as part of their treatment;
  • An anti-PD-1 or anti-PD-L1 treatment regimen must be the last prior therapy before study enrollment, following no more than 2 prior systemic regimens for R/M SCCHN;
  • Acquired resistance to an anti-PD-1- or anti-PD-L1-containing therapy;
  • The participant agrees to undergo a pre-treatment and on-treatment core or excisional biopsy and the biopsy procedure is not judged to be high risk by the Investigator.

Who cannot join

  • All participants:
  • Participant is deemed at high risk of fatal outcome in case of COVID-19;
  • Participants with a history of COVID-19 and have not provided a negative test for SARS CoV-2 infection within 28 days of the planned first dose date with FS118;
  • Prior therapy: Received systemic anti-cancer therapy within 28 days or 5 half-lives, of the first dose of study drug, or prior treatment with a LAG-3 inhibitor;
  • Participants with active or documented history of autoimmune disease;
  • History of uncontrolled intercurrent illness;
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  • Known infections;
  • Uncontrolled CNS metastases, primary CNS tumors, or solid tumors with CNS metastases as only measurable disease;
  • Prior history of or active interstitial lung disease or pneumonitis, encephalitis, seizures, severe immune related adverse events with prior PD-1/PD-L1 containing treatments;
  • Significant cardiac abnormalities;
  • Significant laboratory abnormalities;
  • Intolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the participants's participation in the study, as per the Investigator's judgment.
  • Expansion cohort only:
  • Participant has nasopharynx or thyroid primary tumor site;
  • History of severe immune-related toxicity during the prior treatment with checkpoint inhibitors.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States7 sites

  • Emory Healthcare

    Atlanta, Georgia, 30322

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

Other trials in United States

France5 sites

  • CHU Bordeaux

    Bordeaux

  • Centre Oscar Lambret

    Lille

  • Centre Lyon Berard

    Lyon

  • La Timone

    Marseille

  • Centre Antoine Lacassagne

    Nice

Other trials in France

About this study

Official title: A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.

Being tested
FS118, Paclitaxel
Keywords
FS118, Immuno-oncology, bispecific antibody, check-point inhibitor, dose escalation, cohort expansion, PK, PD, biomarker, LAG-3, PD-L1, SCCHN, F-star
Medical subject headings
Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FS118Drug

    Dosing of participants will occur intravenously (IV) weekly in 3-week treatment cycles until iCPD (i.e., immune confirmed progressive disease), unacceptable toxicity, or discontinuation.

  • PaclitaxelDrug

    Dosing on Days 1, 8 and 15 of each 28 day cycle in combination with FS118 given on days 1, 8, 15 and 22 of each 28 day cycle.

Study groups in NCT03440437
Study groupRoleWhat they receive
FS118 weeklyExperimentalThe 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.
Receives: Drug: FS118; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose escalation: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

    Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03

    Measured: 12 months

  2. Dose escalation: Serum Concentration vs time profile of FS118

    Blood samples for serum PK analysis will be obtained (concentrations measured in mcg/mL)

    Measured: 7 months

  3. Dose escalation: Maximum Serum Concentration of FS118

    Blood samples for serum PK analysis will be obtained (Cmax measured in mcg/mL)

    Measured: 7 months

  4. Dose escalation: Time to reach maximum serum concentration (Tmax) of FS118

    Blood samples for serum PK analysis will be obtained (Tmax measured in hours)

    Measured: 7 months

  5. Dose escalation: Trough serum concentration (Ctrough) of FS118 prior to the next dose

    Blood samples for serum PK analysis will be obtained (Ctrough measured in mcg/mL)

    Measured: 7 months

  6. Dose escalation: Area under the serum FS118 concentration vs time Curve (AUC)

    Blood samples for serum PK analysis will be obtained (AUC measured in d.mcg/mL)

    Measured: 7 months

  7. Dose escalation: Systemic Clearance (CL) of FS118

    Blood samples for serum PK analysis will be obtained (CL measured in mL/day)

    Measured: 7 months

  8. Expansion cohort: Disease control rate as assessed by RECIST 1.1 in evaluable participants with PD-L1 and LAG-3 positive SCCHN

    Assessed by RECIST 1.1

    Measured: 24 weeks

  9. Expansion cohort (FS118 + paclitaxel): Incidence of Treatment Emergent Adverse Events (safety and Tolerability) Incidence, severity and duration of adverse events

    Assessed by CTCAE v 5.0

    Measured: 12 months

Secondary outcomes (9)

  1. Dose escalation: Disease Response as assessed by RECIST 1.1 and iRECIST

    Assessed by RECIST 1.1 and iRECIST

    Measured: 7 months

  2. Dose escalation and expansion cohort of FS118 + paclitaxel

    Incidence of FS118 immunogenicity will include ADA detection and analysis (incidence measured in titre)

    Measured: 7 months

  3. Expansion cohort: Disease Response as assessed by RECIST 1.1 and iRECIST in all SCCHN participants

    Assessed by RECIST 1.1 and iRECIST

    Measured: 24 months

  4. Expansion cohort: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

    Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03

    Measured: 12 months

  5. Expansion cohort: Maximum Serum Concentration of FS118

    Blood samples for serum PK analysis will be obtained (Cmax measured in mcg/mL)

    Measured: 7 months

  6. Expansion cohort: Time to reach maximum serum concentration (Tmax) of FS118

    Blood samples for serum PK analysis will be obtained (Tmax measured in hours)

    Measured: 7 months

  7. Expansion cohort: Trough serum concentration (Ctrough) of FS118 prior to the next dose

    Blood samples for serum PK analysis will be obtained (Ctrough measured in mcg/mL)

    Measured: 7 months

  8. Expansion cohort: Area under the serum FS118 concentration vs time Curve (AUC)

    Blood samples for serum PK analysis will be obtained (AUC measured in d.mcg/mL)

    Measured: 7 months

  9. Expansion cohort: Systemic Clearance (CL) of FS118

    Blood samples for serum PK analysis will be obtained (CL measured in mL/day)

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start16 Apr 2018
  3. Primary completion21 Jun 2024
  4. Study completion21 Jun 2024

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440437
Sponsor's protocol ID
FS118-17101
Status last verified
Jul 2024
First submitted
8 Feb 2018
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yap TA, LoRusso PM, Wong DJ, Hu-Lieskovan S, Papadopoulos KP, Holz JB, Grabowska U, Gradinaru C, Leung KM, Marshall S, Reader CS, Russell R, Sainson RCA, Seal CJ, Shepherd CJ, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clin Cancer Res. 2023 Mar 1;29(5):888-898. doi: 10.1158/1078-0432.CCR-22-1449.

    PubMed 36342102

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FS118 and Paclitaxel in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03440437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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