What is the mechanism of action of this treatment?

Common treatments for solid tumors often involve immunotherapies that enhance the body's immune response to target and destroy cancer cells. Checkpoint inhibitors, such as atezolizumab, work by blocking proteins that prevent immune cells from attacking cancer cells, thereby boosting the immune response. Eciskafusp alfa, currently under study, potentially enhances this immune response through a novel mechanism that complements checkpoint inhibition. This is particularly important for solid tumor patients as it may provide an effective treatment option for those who do not respond to traditional therapies, offering hope for improved outcomes.

What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving immune checkpoint inhibitors like atezolizumab, include inflammation of normal tissues, which can lead to conditions such as pneumonitis, colitis, hepatitis, endocrinopathies, and dermatitis. These side effects occur because the inhibition of immune checkpoints can unmask subclinical autoimmune processes. Additionally, combination therapies may increase the incidence of adverse events such as fatigue, rash, diarrhea, and infusion-related reactions. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors focus on enhancing the immune response, particularly through checkpoint inhibition. Notable drugs include nivolumab and pembrolizumab, both of which are PD-1 inhibitors that help the immune system recognize and attack cancer cells. Atezolizumab, a PD-L1 inhibitor, is another approved drug that blocks the interaction between PD-1 and PD-L1, thereby enhancing immune response. These drugs have shown efficacy in various solid tumors, including non-small cell lung cancer and melanoma. The investigational drug eciskafusp alfa, being studied in combination with atezolizumab, potentially enhances the immune response through a novel mechanism that complements these existing checkpoint inhibitors.

What other types of research exist?

Promising novel alternatives to Eciskafusp alfa for solid tumor patients include: 1) Pembrolizumab, which has shown efficacy in combination with chemotherapy for various solid tumors. 2) Nivolumab, often used in combination with Ipilimumab, has demonstrated significant activity in multiple solid tumors. 3) Atezolizumab, particularly in combination with other agents like bevacizumab or chemotherapy, has shown promising results. 4) Cabozantinib combined with Atezolizumab, which has shown efficacy in renal cell carcinoma and may be applicable to other solid tumors. These alternatives leverage immune checkpoint inhibition and other mechanisms to enhance anti-tumor activity.

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Monoclonal Antibodies

Eciskafusp Alfa + Atezolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status 0 to 1

No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments

Must not have

Hepatitis B virus (HBV) or hepatitis C virus infection

Untreated central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until end of part 1 and part 2 (up to approximately 1.5 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called eciskafusp alfa alone and with atezolizumab in adults with certain types of cancer. These drugs help the immune system attack cancer cells. Atezolizumab is an approved treatment for various cancers, including bladder cancer and lung cancer.

Who is the study for?

This trial is for adults with advanced solid tumors that have no standard treatments available or can't tolerate them. Participants should have a life expectancy of at least 12 weeks, measurable disease, and be in relatively good health (able to perform daily activities without significant assistance). They must not have severe allergies to certain antibodies or proteins, untreated brain metastases, other active cancers, certain viral infections like HIV or hepatitis B/C, recent major surgeries or injuries.

What is being tested?

The study tests Eciskafusp Alfa alone and combined with Atezolizumab in patients whose solid tumors might respond to checkpoint inhibitors. The goal is to evaluate the safety and how well these treatments shrink tumors over a maximum period of 28 months.

What are the potential side effects?

Potential side effects include allergic reactions related to the immune system's response to treatment components such as chimeric/humanized antibodies. Other risks may involve complications from rapid tumor progression if present and any issues arising from pre-existing conditions that are uncontrolled.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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No standard treatments work for me or I can't tolerate them.

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My cancer cannot be removed by surgery and may have spread.

Exclusion Criteria

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

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I have hepatitis B or C.

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I have brain metastases that have not been treated.

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I have another type of cancer at the same time.

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My cancer is quickly getting worse, threatening vital organs.

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I am HIV positive.

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I have fluid in both sides of my chest.

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I am not allergic to any part of the treatment, including Chinese hamster ovary cell products.

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I have brain metastases that don't cause symptoms and have been treated.

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I have pain from my cancer that isn't managed by medication or I have high calcium levels causing symptoms.

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I do not have any active or uncontrolled infections.

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I have or had cancer spread to the lining of my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until end of part 1 and part 2 (up to approximately 1.5 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until end of part 1 and part 2 (up to approximately 1.5 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until end of part 1 and part 2 (up to approximately 1.5 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

Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Part 3

Percentage of Participants with Adverse Events in Part 1 and Part 2

Percentage of Participants with Dose-Limiting Toxicities in Part 1 and Part 2

Secondary study objectives

Blood Tumor Mutational Burden

Change from Baseline in Percentage of Immune Cell Subsets

Change from Baseline in Percentage of Immune Markers

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Eciskafusp Alfa in Combination with AtezolizumabExperimental Treatment2 Interventions

Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab.

Group II: Eciskafusp Alfa as a Single Agent and/or with AtezolizumabExperimental Treatment2 Interventions

Part 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab.

Group III: Eciskafusp Alfa as a Single AgentExperimental Treatment1 Intervention

Part 1: Dose-escalation of eciskafusp alfa as a single agent. eciskafusp alfa will be either an intravenous administration (IV) or subcutaneous administration (SC) in multiple-ascending doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

0 / 14Eligibility 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

Common treatments for solid tumors often involve immunotherapies that enhance the body's immune response to target and destroy cancer cells. Checkpoint inhibitors, such as atezolizumab, work by blocking proteins that prevent immune cells from attacking cancer cells, thereby boosting the immune response. Eciskafusp alfa, currently under study, potentially enhances this immune response through a novel mechanism that complements checkpoint inhibition. This is particularly important for solid tumor patients as it may provide an effective treatment option for those who do not respond to traditional therapies, offering hope for improved outcomes.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.