What side effects are associated with this type of intervention?

Common treatments for cancer similar to the FS120 trial, which involves immune checkpoint inhibitors and chemotherapy, include pembrolizumab, atezolizumab, and nivolumab. The known side effects of these treatments often include severe adverse events such as neutropenia, diarrhea, nausea, rash, pneumonia, chronic obstructive pulmonary disease, and pneumonitis. Additionally, immune-related adverse events can occur, including colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy-related side effects typically include fatigue, nausea, vomiting, sensory neuropathy, and hearing loss.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs that enhance T-cell activation and proliferation for the treatment of various cancers. Pembrolizumab (Keytruda) and atezolizumab (Tecentriq) are notable examples. Pembrolizumab is approved for use in cancers such as non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma, among others. Atezolizumab is approved for use in NSCLC, small cell lung cancer (SCLC), and urothelial carcinoma. These drugs work by inhibiting the PD-1/PD-L1 pathway, thereby enhancing the immune system's ability to attack cancer cells.

What other types of research exist?

Promising novel alternatives to FS120 for cancer treatment include: 1) Atezolizumab in combination with carboplatin and etoposide, which has shown improved overall survival and progression-free survival in extensive-stage small cell lung cancer. 2) Durvalumab plus platinum-etoposide, which has also demonstrated improved survival outcomes in extensive-stage small cell lung cancer. 3) Pembrolizumab in combination with chemotherapy, which has shown significant improvements in overall survival and progression-free survival in advanced non-small cell lung cancer. 4) CD3 x CD19 bispecific antibody, which has demonstrated efficient activation and cytotoxicity of T cells against B cell malignancies.

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Monoclonal Antibodies

FS120 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by invoX Pharma Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For monotherapy part: participants must have histologically confirmed, locally advanced, unresectable or metastatic solid tumors of specific types

Age ≥18 years

Must not have

Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years

Prior systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, before the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system's enhancement which may affect organs, cause fatigue or flu-like symptoms. Specific side effects will depend on how FS120 interacts with the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My cancer is advanced, cannot be surgically removed, and pembrolizumab is approved for my condition.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I am HIV-positive with a history of Kaposi sarcoma or Castleman Disease.

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I have had severe side effects from previous immune therapy that haven't improved.

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I have not had radiotherapy in the last 2 weeks.

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I have not received a live vaccine in the last 30 days.

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I do not have uncontrolled brain metastases or tumors.

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I have been treated with immune-checkpoint inhibitors more than once.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FS120Experimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cancer treatments often include immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, such as the OX40/CD137 bispecific antibody studied in the FS120 trial, works by enhancing the body's immune response against cancer cells. This particular antibody targets OX40 and CD137, proteins that stimulate T-cell activation and proliferation, thereby boosting the immune system's ability to attack cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapy involves drugs designed to target specific molecules involved in cancer growth and survival, minimizing damage to normal cells. These treatments are crucial for cancer patients as they offer different mechanisms to control or eliminate cancer, potentially improving survival rates and quality of life.

Targeting BCMA in Multiple Myeloma.Pediatric acute lymphoblastic leukemia.