FS118 First in Human Study in Patients With Advanced Malignancies
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ClinicalTrials.gov Identifier: NCT03440437 |
Recruitment Status :
Recruiting
First Posted : February 22, 2018
Last Update Posted : March 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Cancer Metastatic Cancer Squamous Cell Carcinoma of Head and Neck | Drug: FS118 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients With Advanced Malignancies |
Actual Study Start Date : | April 16, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: FS118 weekly
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.
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Drug: FS118
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. |
- Dose escalation: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 months ]Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03
- Dose escalation: Serum Concentration vs time profile of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (concentrations measured in mcg/mL)
- Dose escalation: Maximum Serum Concentration of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Cmax measured in mcg/mL)
- Dose escalation: Time to reach maximum serum concentration (Tmax) of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Tmax measured in hours)
- Dose escalation: Trough serum concentration (Ctrough) of FS118 prior to the next dose [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Ctrough measured in mcg/mL)
- Dose escalation: Area under the serum FS118 concentration vs time Curve (AUC) [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (AUC measured in d.mcg/mL)
- Dose escalation: Systemic Clearance (CL) of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (CL measured in mL/day)
- Expansion cohort: Disease control rate as assessed by RECIST 1.1 in evaluable participants with PD-L1 and LAG-3 positive SCCHN [ Time Frame: 24 weeks ]Assessed by RECIST 1.1
- Dose escalation: Disease Response as assessed by RECIST 1.1 and iRECIST [ Time Frame: 7 months ]Assessed by RECIST 1.1 and iRECIST
- Dose escalation: Incidence of FS118 immunogenicity [ Time Frame: 7 months ]Incidence of FS118 immunogenicity will include ADA detection and analysis (incidence measured in titre)
- Expansion cohort: Disease Response as assessed by RECIST 1.1 and iRECIST in all SCCHN participants [ Time Frame: 24 weeks ]Assessed by RECIST 1.1 and iRECIST
- Expansion cohort: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 months ]Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03
- Expansion cohort: Maximum Serum Concentration of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Cmax measured in mcg/mL)
- Expansion cohort: Time to reach maximum serum concentration (Tmax) of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Tmax measured in hours)
- Expansion cohort: Trough serum concentration (Ctrough) of FS118 prior to the next dose [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (Ctrough measured in mcg/mL)
- Expansion cohort: Area under the serum FS118 concentration vs time Curve (AUC) [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (AUC measured in d.mcg/mL)
- Expansion cohort: Systemic Clearance (CL) of FS118 [ Time Frame: 7 months ]Blood samples for serum PK analysis will be obtained (CL measured in mL/day)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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;
- 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.
Exclusion Criteria:
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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440437
Contact: F-star Clinical Trials | +1 617 798 1467 | cambridge@f-star.com | |
Contact: F-star Clinical Trials | +44 1223 497400 |
United States, California | |
University of California Los Angeles (UCLA) | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Deborah Wong, MD, PhD | |
United States, Connecticut | |
Yale University School of Medicine | Active, not recruiting |
New Haven, Connecticut, United States, 06520 | |
United States, Georgia | |
Emory Healthcare | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Nabil Saba, MD | |
Principal Investigator: Nabil Saba | |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Muhammad Riaz, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Roger Cohen, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sarina A Piha-Paul, MD | |
South Texas Accelerated Research Therapeutics | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Kyri Papadopoulos, MD |
Responsible Party: | F-star Therapeutics Limited |
ClinicalTrials.gov Identifier: | NCT03440437 |
Other Study ID Numbers: |
FS118-17101 |
First Posted: | February 22, 2018 Key Record Dates |
Last Update Posted: | March 4, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
FS118 Immuno-oncology bispecific antibody check-point inhibitor dose escalation cohort expansion PK |
PD biomarker LAG-3 PD-L1 SCCHN F-star |
Squamous Cell Carcinoma of Head and Neck Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Head and Neck Neoplasms Neoplasms by Site |