Advanced CancerPhase 1NCT04648202
FS120 Phase 1/1b Study in Patients With Advanced Malignancies
A Phase 1 study testing FS120 in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 9 sites in 2 countries.
Trial summary
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- FS120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 18 Nov 2020to 1 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable disease
- Eastern Cooperative Oncology Group Performance Status 0-1.
- Highly effective contraception if risk of conception exists
- A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception
- Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes
- For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent
Who cannot join
- Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.
- Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).
- Prior radiotherapy within 2 weeks of start of study treatment.
- HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, 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; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.
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- Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 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 judgement.
- Vaccination with a live vaccine within 30 days before first dose of study drug.
- Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.
- Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Spain5 sites
NEXT Oncology, Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States4 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Yale University
New Haven, Connecticut, 06511
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- FS120
- Keywords
- Immuno-oncology, Bispecific antibody, Dose escalation, Cohort expansion, OX40, CD137 (4-1BB), invoX, Pembrolizumab, PD-1
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS120Drug
Also called Pembrolizumab (KEYTRUDA®)
Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| FS120 | Experimental | Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts Receives: Drug: FS120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
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.
Measured: 24 months
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start18 Nov 2020
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- invoX Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648202
- Sponsor's protocol ID
- FS120-19101
- Other IDs
- 2021-002820-19, MK-3475-C82, KEYNOTE-C82
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2020
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04648202
- Acronym / sponsor ID
- FS120-19101
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Immuno-oncology, Bispecific antibody, Dose escalation, Cohort expansion, OX40, CD137 (4-1BB), invoX, Pembrolizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- invoX Pharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS120 | Experimental | Drug: FS120Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Measurable disease
- Eastern Cooperative Oncology Group Performance Status 0-1.
- Highly effective contraception if risk of conception exists
- A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception
- Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes
Key exclusion criteria (10 listed)
- Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.
- Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).
- Prior radiotherapy within 2 weeks of start of study treatment.
- HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS120Also: Pembrolizumab (KEYTRUDA®)Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity. | Drug | FS120 |
Primary outcome
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
Time frame: 24 months
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.
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Time frame: 24 months
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FS120 in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.