Eciskafusp Alfa + Atezolizumab for Cancer

Not currently recruiting at 26 trial locations

Overseen By Reference Study ID Number: BP41628 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must not be taking: IL-2/IL-15 cytokines

Disqualifiers: CNS metastases, HIV, Hepatitis, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with advanced solid tumors, which are cancers forming in organ tissues. Researchers aim to evaluate the effectiveness of a drug called eciskafusp alfa, both alone and in combination with atezolizumab (Tecentriq), an immunotherapy that aids the immune system in fighting cancer. They seek participants whose tumors might respond to this treatment and who have exhausted standard treatment options. This trial may suit those with a measurable solid tumor that cannot be surgically removed or has spread, and who have no remaining treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eciskafusp alfa is a new treatment being tested in humans for the first time, so no previous safety information exists. However, when combined with atezolizumab, a drug already used to treat some cancers, more information is available. Atezolizumab is generally well-tolerated in treating cancers like bladder cancer and a type of lung cancer, though it has some known side effects.

Since this is an early-stage study, the main goal is to observe how people respond to eciskafusp alfa alone and in combination with atezolizumab. This phase helps researchers learn about any possible side effects and assess the treatments' safety. Ensuring participant safety is a top priority, and researchers will closely monitor participants for any negative reactions during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Eciskafusp Alfa because it offers a unique approach to treating cancer by possibly enhancing the immune response against tumors. Unlike standard cancer treatments, which often focus on directly attacking cancer cells or blocking growth signals, Eciskafusp Alfa works by stimulating immune cells to better recognize and fight cancer. Additionally, the combination of Eciskafusp Alfa with Atezolizumab could potentially amplify this immune response, offering a new strategy that might improve outcomes for patients. This novel mechanism of action sets it apart from current therapies and provides hope for more effective cancer treatments.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that eciskafusp alfa, one of the treatments in this trial, yields promising results in treating cancers like lung and breast cancer by improving survival rates compared to traditional chemotherapy. This treatment, also known as PD1-IL2v, is a new type of immunotherapy that enhances the immune system's ability to attack cancer cells. Early studies suggest it kills tumor cells more effectively than some current treatments.

Atezolizumab, another treatment option in this trial, has already been proven to extend the lives of patients with advanced non-small cell lung cancer when used alone. In this trial, some participants will receive eciskafusp alfa alone, while others will receive it combined with atezolizumab. Combining eciskafusp alfa with atezolizumab might enhance these benefits by leveraging the strengths of both treatments. Together, they aim to create a stronger defense against cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Life expectancy of >=12 weeks

Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

I am fully active or can carry out light work.

Exclusion Criteria

I have hepatitis B or C.

I have brain metastases that have not been treated.

I have another type of cancer at the same time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation (Part 1)

Dose-escalation of eciskafusp alfa as a single agent

1.5 months

Multiple visits for dose administration and monitoring

Dose-Escalation (Part 2)

Dose-escalation of eciskafusp alfa in combination with atezolizumab

1.5 months

Multiple visits for dose administration and monitoring

Extension (Part 3)

Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab

26 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• RO7284755

Trial Overview 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.

How Is the Trial Designed?

Group I: Eciskafusp Alfa in Combination with Atezolizumab Experimental Treatment 2 Interventions

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

Group II: Eciskafusp Alfa as a Single Agent and/or with Atezolizumab Experimental Treatment 2 Interventions

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

Group III: Eciskafusp Alfa as a Single Agent Experimental Treatment 1 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.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Atezolizumab, a monoclonal antibody targeting PD-L1, has shown significant improvements in progression-free and overall survival in patients with advanced non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) when combined with chemotherapy, as demonstrated in the IMpower studies.

The safety profile of atezolizumab in combination with chemotherapy is acceptable, with common immune-related adverse events including rash (18-28%), hypothyroidism (8-15%), and hepatitis (5-17%), consistent with its known effects as a single agent, indicating no new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. Manzo, A., Carillio, G., Montanino, A., et al.[2022]

Atezolizumab, an anti-PD-L1 therapy, was well tolerated in a study of 45 patients with advanced melanoma, showing that most side effects were mild (grade 1/2) and no treatment-related deaths occurred.

The treatment resulted in a 30% overall response rate and a median overall survival of 23 months, with certain biomarkers like PD-L1 expression and tumor mutational burden linked to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Hamid, O., Molinero, L., Bolen, CR., et al.[2020]

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab, a PD-L1 blocking antibody, shows higher rates of objective response, progression-free survival, and overall survival when used as a first-line therapy in chemotherapy-naïve patients with metastatic non-small cell lung cancer (NSCLC), compared to its use in later treatment lines.

The review included 15 ongoing studies, with 5 reporting results, indicating that atezolizumab is being explored in various treatment combinations and settings, suggesting its potential as a versatile first-line treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. Ryu, R., Ward, KE.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04303858

NCT04303858 | A Study to Evaluate Safety and Anti-Tumor ... This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/cancer/solid-tumors/a-study-to-evaluate-safety-and-anti-tumor-activity-of-r-73278.html

Clinical Trial - A Study to Evaluate Safety and Anti-Tumo... Find out more about the clinical trial for Solid Tumors. This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10072055/

PD-1 cis-targeting of an IL-2Rβγ-biased interleukin-2 ... PD1-IL2v (RG6279, eciskafusp alfa) became the first PD-1 targeted immunocytokine entering clinical trials 2020, and is currently in Phase 1b ...

4. withpower.com withpower.com/trial/phase-1-neoplasms-4-2020-69b41

Eciskafusp Alfa + Atezolizumab for Cancer It has shown promising results in various cancers, including lung and breast cancer, by improving overall survival rates compared to traditional chemotherapy.

5. science.org science.org/doi/10.1126/scitranslmed.adr3718

PD-1–targeted cis-delivery of an IL-2 variant induces a ... In addition, tumor cell killing was increased upon PD1-IL2v treatment compared with combined treatment with anti-PD1 and isotype-IL2v (P = ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-safety-and-anti-tumor-activity-of-eciskafusp-alfa-ro7284755-alone-or-in-combin

A Study to Evaluate Safety and Anti-Tumor Activity of ... This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT04303858

A Study to Evaluate Safety and Anti-Tumor Activity of ... A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced ...