FS222 First in Human Study in Patients With Advanced Malignancies

Launched by INVOX PHARMA LIMITED · Feb 3, 2021

Keywords

ClinConnect Summary

The FS222 clinical trial is a first-in-human study exploring a new treatment called FS222 for adults with advanced cancer that has not responded to standard therapies. This study aims to understand how safe the treatment is, how well it is tolerated by patients, and to determine the best dose for future studies. Participants will be closely monitored for any side effects and will undergo tests to measure how the drug works in their bodies.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced or metastatic solid tumors that have not responded to other treatments. They should have received no more than one prior line of immune checkpoint blockade (ICB) therapy, and they must agree to have a biopsy of their tumor before and during the study. Participants can expect regular visits to the clinic for assessments and treatment, and they will be required to provide informed consent to ensure they understand the study's purpose and procedures. It's important to note that individuals with certain health conditions, active infections, or recent vaccinations may not qualify for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• • Participants with histologically or cytologically confirmed, locally advanced, unresectable or metastatic solid tumours for whom standard therapy has proven to be ineffective, intolerable or is considered inappropriate. This criterion does not apply to the PK/PD expansion cohort, where tumour-specific criteria will apply instead.
• • No more than 1 line of prior therapy with ICB treatment. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
• • Participants who have received prior ICB, or any concurrent chemotherapy, radiotherapy, investigational, biologic or hormonal therapy for cancer treatment may be eligible for enrolment following a washout period.
• • Participants who have received prior anti-PD-L1 therapy are eligible if PD-L1 therapy was discontinued ≥6 months prior to entry into the study.
• • Participants who have failed a prior ICB regimen should document it.
• • Measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
• • Eastern Cooperative Oncology Group Performance Status ≤1.
• • The participant agrees to undergo a mandatory pre-treatment and on-treatment biopsy of the tumour. Certain exceptions apply.
• • 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.
• • Concurrent enrolment in another clinical study with the exception of non-interventional/observational studies or the follow-up period of an interventional study.
• • Prior treatment with CD137 agonist mAb or other experimental agonists.
• • For participants who have received prior ICB, participants must not have received more than 1 line of prior treatment with ICB(s). Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
• • Participants with active autoimmune disease.
• • Receipt of any live virus vaccine within 30 days prior to the first dose of study drug.
• • Receipt of a live attenuated vaccine within 30 days prior to the first dose of study drug.
• • History of uncontrolled intercurrent illness.
• • Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
• • Judgment by the investigator that the participant is unsuitable to participate in the study, and the participant is unlikely to comply with study procedures, restrictions and requirements.
• • Significant laboratory abnormalities.
• • Known infections.
• • Uncontrolled CNS metastases, primary CNS tumours with CNS metastases as only measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
• • Prior history of any Grade ≥3 irAE that has not improved to Grade ≤1, except for endocrine deficiencies that are managed by HRT; significant treatment-related cytokine release syndrome; systemic inflammatory response syndrome.
• • Current use of immunosuppressive agents, prior organ transplantation requiring immunosuppression, hypersensitivity or intolerance to mAb or their excipients, or persisting toxicity related to prior therapy of Grade \>1 NCI CTCAE Version 5.0 .