Status:
TERMINATED
A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies
Lead Sponsor:
invoX Pharma Limited
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-cen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03440437
Start Date
April 16 2018
End Date
June 21 2024
Last Update
July 1 2025
Active Locations (12)
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1
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
Emory Healthcare
Atlanta, Georgia, United States, 30322
4
University of Cincinnati
Cincinnati, Ohio, United States, 45219