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First human trial of FS222 for advanced cancer patients

A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies

Phase 1 Interventional invoX Pharma Limited · NCT04740424

This study is testing a new treatment called FS222 to see if it is safe and effective for adults with advanced cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment260 (estimated)
Ages18 Years and up
SexAll
SponsorinvoX Pharma Limited Industry-sponsored
Drugs / interventionschemotherapy
Locations21 sites (Waratah, New South Wales and 20 other locations)
Trial IDNCT04740424 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study aims to evaluate the safety, tolerability, pharmacokinetics, and activity of FS222 in adult patients with advanced malignancies. It will involve multiple doses and is designed to identify the maximum tolerated dose and/or recommended Phase 2 dose for the treatment. Participants will be closely monitored for pharmacodynamics, immunogenicity, and response to the treatment. The study is open-label and multi-center, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, unresectable, or metastatic solid tumors who have not benefited from standard treatments.

Not a fit: Patients with early-stage cancer or those who have not yet undergone any prior therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have not responded to standard therapies.

How similar studies have performed: Other studies in immuno-oncology have shown promising results with similar bispecific antibody approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 .

Where this trial is running

Waratah, New South Wales and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced CancerMetastatic CancerImmuno-oncologybispecific antibodydose escalationcohort expansionCD137PD-L1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.