FS120 First in Human Study in Patients With Advanced Malignancies

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: F-star Beta Limited; F-star Therapeutics Limited

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.