FS120 for Advanced Cancer

Not currently recruiting at 8 trial locations

Overseen By invoX Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: invoX Pharma Limited

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: CNS metastases, Severe hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FS120, designed to combat advanced cancers. Researchers aim to determine if FS120 is safe and effective in shrinking tumors. They are testing FS120 alone and in combination with pembrolizumab, an immunotherapy drug already used for some cancers. Individuals with advanced cancer that cannot be surgically removed and who have not recently undergone cancer treatments might be suitable candidates. Participants should also be in good general health and free from certain other medical conditions. As a Phase 1 trial, participants will be among the first to receive FS120, aiding researchers in understanding how this new treatment works in people.

Will I have to stop taking my current medications?

The trial requires that you stop any prior systemic anticancer therapy at least 28 days before starting the study drug. If you are on other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that FS120 is likely to be safe for humans?

Research shows that FS120, a new treatment for advanced cancer, appears promising and is generally well-tolerated. Earlier studies suggest that FS120 might be effective without causing excessive side effects. However, like many new treatments, there is a risk of serious side effects, and some individuals might experience severe reactions. It is important to note that this treatment remains in the early testing stages, so researchers are primarily focused on assessing its safety for humans. This phase of research is crucial for understanding how the body reacts to FS120 and ensuring its safety for further study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FS120 is unique because it works by targeting OX40 and CD137, which are proteins that can enhance the immune system's ability to fight cancer. Unlike traditional treatments like chemotherapy, which attack cancer cells directly, FS120 aims to boost the body's natural immune response. Researchers are excited about FS120 because it has the potential to work alongside pembrolizumab, a well-established immunotherapy, to enhance its effects and possibly lead to better outcomes for patients with advanced cancer. This combination approach could offer a new avenue for treatment, especially for those who have not responded well to existing therapies.

What evidence suggests that FS120 might be an effective treatment for advanced cancer?

Research has shown that FS120, a special type of antibody, can enhance the immune system's ability to fight cancer. In studies with mice, FS120 improved T cell activity, slowed tumor growth, and increased survival when combined with anti-PD-1 therapy, such as pembrolizumab. In this trial, FS120 will be administered either as monotherapy or in combination with pembrolizumab. This suggests FS120 might help the body better identify and attack cancer cells. Early findings also indicate that FS120 is well-tolerated, suggesting it might be safe to use. While more research is needed, these early results are promising for FS120's potential to treat advanced cancers. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced cancers eligible for pembrolizumab can join this trial. They must have measurable disease, be in good physical condition, and agree to biopsies. HIV-positive participants are allowed if they're healthy. Women must use effective contraception or not be of childbearing potential.

Inclusion Criteria

I am not pregnant, breastfeeding, and if able to bear children, I use effective birth control.

My cancer is advanced, cannot be surgically removed, and is of a specific type.

I agree to have a biopsy before and during treatment.

Exclusion Criteria

I have another cancer that is growing or was treated in the last 3 years.

I haven't had cancer treatment in the last 28 days or 5 half-lives of the drug, whichever is shorter.

I have not had treatments targeting OX40, CD137, CD40, GITR, or CD27.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FS120, an OX40/CD137 Bispecific Antibody, alone or in combination with pembrolizumab in dose escalation and expansion cohorts

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FS120

Trial Overview FS120, a new cancer drug targeting two immune system proteins (OX40/CD137), is being tested alone and alongside Pembrolizumab to see its safety and effectiveness against various advanced solid tumors.

How Is the Trial Designed?

Group I: FS120 Experimental Treatment 1 Intervention

Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts

Who Is Running the Clinical Trial?

invoX Pharma Limited

Lead Sponsor

Trials

4

Recruited

400+

F-star Therapeutics Limited

Lead Sponsor

Trials

3

Recruited

340+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

A meta-analysis of 10 randomized controlled trials involving 4,679 cancer patients found that vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) are associated with a 1.5% incidence of fatal adverse events (FAEs), which is significantly higher than in control patients.

The relative risk of experiencing FAEs for patients treated with VEGFR TKIs was 2.23, indicating more than double the risk compared to those not receiving these treatments, highlighting the need for careful monitoring of patients on these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of randomized controlled trials for the incidence and risk of treatment-related mortality in patients with cancer treated with vascular endothelial growth factor tyrosine kinase inhibitors. Schutz, FA., Je, Y., Richards, CJ., et al.[2022]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

In a systematic review of 17 randomized controlled trials involving 6,982 patients with solid tumors, VEGFR2-targeted agents were found to have an overall incidence of fatal adverse events (FAEs) of only 1.7%.

The study concluded that the use of VEGFR2-targeted agents did not significantly increase the risk of FAEs compared to control treatments, indicating a favorable safety profile for these cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk of Fatal Adverse Events in Cancer Patients Treated With Vascular Endothelial Growth Factor Receptor 2-Targeted Agents: A Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials. Zhao, B., Zhao, H., Zhao, J.[2020]

Aflibercept, used in cancer treatment, was found to increase the risk of fatal adverse events (FAEs) in patients, with an overall incidence of 5.1% among 3,060 patients analyzed from ten clinical trials.

The most common causes of FAEs linked to aflibercept were infections (38.8%), hemorrhage (5.9%), and gastrointestinal perforation (5.9%), indicating that while aflibercept is effective, careful monitoring for these serious side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-related mortality with aflibercept in cancer patients: a meta-analysis. Qi, WX., Tang, LN., Shen, Z., et al.[2021]

HER2-positive metastatic breast cancer is more aggressive and often develops resistance to treatments compared to HER2-negative tumors, making effective management crucial.

Trastuzumab is the standard treatment for HER2-positive cases, but lapatinib has been developed as a targeted therapy that works inside the cell to disrupt harmful signaling pathways, offering a potential solution to overcome resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming treatment challenges in advanced breast cancer. Harkins, B., Geyer, CE.[2018]

Citations

1. withpower.com withpower.com/trial/phase-1-neoplasm-metastasis-10-2020-1aebc

FS120 for Advanced Cancer · Info for Participants This trial is testing FS120, a medicine that strengthens the immune system, alone and with Pembrolizumab, which helps the immune system attack cancer, ...

2. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04648202/

Clinical Trial: NCT04648202 - Solid Tumor This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)03646-2/pdf

A first-in-human phase I study of FS120, an OX40/CD137 ... FS120 has the potential to deliver tumor-agnostic clinical efficacy with good tolerability. Trial design: This FiH study is an open-label dose escalation and ...

4. jitc.bmj.com jitc.bmj.com/content/9/Suppl_2/A602

573 FS120, an OX40/CD137 tetravalent bispecific dual ... We demonstrate the ability of FS120 to improve anti-PD-1 induced T cell activity, increasing tumor growth inhibition and survival, in syngeneic mouse tumor ...

5. biospace.com biospace.com/f-star-therapeutics-to-present-fs120-phase-1-trial-in-progress-update-at-esmo-2021preclinical-data-indicates-a-broad-therapeutic-window-for-f-star-s-first-in-class-tetravalent-dual-t-cell-agonist

F-star Therapeutics to Present FS120 Phase 1 Trial-in- ... FS120 has the potential to deliver tumor-agnostic clinical efficacy with good tolerability. About F-star Therapeutics, Inc. F-star is a clinical ...

6. f-star.com f-star.com/wp-content/uploads/2022/09/F-star-Therapeutics-to-Present-FS120-Phase-1-Trial-in-Progress-Update-at-ESMO-2021.pdf

F-star Therapeutics to Present FS120 Phase 1 Trial-in- ... Safety and PK/PD data from this study will be used to trigger the initiation of the previously announced FS120 and KEYTRUDA® (pembrolizumab) combination study, ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)03646-2/fulltext

1033TiP A first-in-human phase I study of FS120, an OX40 ... FS120 has the potential to deliver tumor-agnostic clinical efficacy with good tolerability.

8. ctv.veeva.com ctv.veeva.com/study/fs120-first-in-human-study-in-patients-with-advanced-malignancies

FS120 Phase 1/1b Study in Patients With Advanced ... This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody.