Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740424




Registration number
NCT04740424
Ethics application status
Date submitted
28/01/2021
Date registered
5/02/2021
Date last updated
1/07/2025

Titles & IDs
Public title
FS222 First in Human Study in Patients With Advanced Malignancies
Scientific title
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
Secondary ID [1] 0 0
FS222-19101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Metastatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FS222

Experimental: FS222 Q4W - 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. Additional participants will be recruited into the PK/PD expansion cohorts at dose levels deemed safe during dose escalation. Once a tolerated dose has been established participants will be recruited into tumour-specific expansion cohorts.


Treatment: Drugs: FS222
Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
15 months
Primary outcome [2] 0 0
Determination of a maximum tolerated dose (MTD) by evaluation of DLTs
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Determination of a recommended Phase 2 dose (RP2D) by evaluation of DLTs
Timepoint [3] 0 0
28 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 .

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2027
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
One Clinical Research Perth - Perth
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Württemberg
Country [3] 0 0
Netherlands
State/province [3] 0 0
Gelderland
Country [4] 0 0
Poland
State/province [4] 0 0
Wielkopolskie
Country [5] 0 0
Poland
State/province [5] 0 0
Kraków
Country [6] 0 0
Romania
State/province [6] 0 0
Bucharest
Country [7] 0 0
Romania
State/province [7] 0 0
Cluj-Napoca
Country [8] 0 0
Spain
State/province [8] 0 0
Navarra
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Spain
State/province [10] 0 0
Las Palmas De Gran Canaria
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Majadahonda
Country [13] 0 0
Spain
State/province [13] 0 0
Seville
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
invoX Pharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
invoX Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+44 2038 820886
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04740424