Description:
This study will be conducted in adult participants diagnosed with advanced tumors to
characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS120. This is
a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to
systematically assess safety and tolerability, and to identify the maximum tolerated dose
(MTD) and/or recommended Phase 2 dose (RP2D) for FS120 in participants with advanced tumors.
Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Title
- Brief Title: FS120 First in Human Study in Patients With Advanced Malignancies
- Official Title: A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS120, an OX40/CD137 Bispecific Antibody, in Subjects With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
FS120-19101
- NCT ID:
NCT04648202
Conditions
- Advanced Cancer
- Metastatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
FS120 | | FS120 Q4W |
Purpose
This study will be conducted in adult participants diagnosed with advanced tumors to
characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS120. This is
a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to
systematically assess safety and tolerability, and to identify the maximum tolerated dose
(MTD) and/or recommended Phase 2 dose (RP2D) for FS120 in participants with advanced tumors.
Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Trial Arms
Name | Type | Description | Interventions |
---|
FS120 Q4W | Experimental | 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. | |
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years.
- Participants with histologically confirmed, locally advanced, unresectable, or
metastatic solid tumours that have failed up to 2 prior regimens for metastatic
disease and standard therapy has proven to be ineffective, intolerable, or is
considered inappropriate.
- For participants who have failed 1 prior immune-checkpoint blockade (ICB)-containing
regimen, prior biomarker status must be documented; the minimum treatment duration was
12 weeks; and disease progression is documented for participants in the accelerated
titration and confirmed for participants in later cohorts.
- Measurable disease.
- Eastern Cooperative Oncology Group Performance Status ≤1.
- The participant agrees to undergo a pretreatment and on-treatment biopsy of the tumor.
- Highly effective contraception.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Participants with clinically relevant COVID-19 disease risk will be excluded from
enrolment during the COVID-19 pandemic.
- Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or
CD27 targeting therapy (single agent or combination); prior therapy with more than 1
line of treatment with immune-checkpoint inhibitors (including ICB combination
therapy).
- Participants with active autoimmune disease.
- History of uncontrolled intercurrent illness.
- Significant laboratory abnormalities.
- Participants with haematological malignancies; participants with treatment-refractory
chronic bone marrow insufficiency; participants unresponsive and/or refractory to
transfusions and supportive care for disease-related or treatment-related
haematological toxicity(ies).
- Participants with prior allogeneic or autologous bone marrow transplantation or other
solid organ transplantation.
- Known infections.
- Uncontrolled central nervous system (CNS) metastases, primary CNS tumours, or solid
tumours with CNS metastases as the only measurable disease.
- Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade
≤1; significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release
syndrome (CRS); systemic inflammatory response syndrome (SIRS).
- Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal
antibodies or their excipients, persistent grade >1 NCI CTCAE Version 5.0 toxicity
related to prior therapy or any condition that would significantly impair and/or
prohibit the participant's participation in the study, as per the investigator's
judgment.
- Vaccination with a live vaccine within 30 days before first dose of study drug.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs) |
Time Frame: | 15 months |
Safety Issue: | |
Description: | Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | F-star Beta Limited |
Trial Keywords
- Immuno-oncology
- bispecific antibody
- dose escalation
- cohort expansion
- OX40
- CD137
- F-star
Last Updated
March 10, 2021