FS120 for Advanced Cancer

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

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing FS120, a medicine that strengthens the immune system, alone and with Pembrolizumab, which helps the immune system attack cancer, in patients with advanced cancer. Pembrolizumab is a medicine used to treat various cancers by enhancing the immune system's ability to attack cancer cells.

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.

What safety data exists for FS120 or similar treatments in humans?

Molecular target anticancer drugs, which may include treatments like FS120, have been associated with an increased risk of serious adverse events (SAEs) and fatal adverse events (FAEs) compared to placebo. The overall incidence of SAEs was about 27%, and FAEs was about 2.3%, indicating a need for careful monitoring when using these drugs. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. India 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Overcoming treatment challenges in advanced breast cancer. [2018]

3. Switzerland 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. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Treatment-related mortality with aflibercept in cancer patients: a meta-analysis. [2021]

5. United States 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. [2022]