189 Participants Needed

Eciskafusp Alfa + Atezolizumab for Cancer

Recruiting at 24 trial locations
Bw
Bh
RS
Overseen ByReference Study ID Number: BP41628 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Atezolizumab in treating cancer?

Atezolizumab has shown effectiveness in treating various cancers, including urothelial carcinoma and non-small cell lung cancer, by improving overall survival rates in clinical trials. It has also been approved for use in metastatic triple-negative breast cancer, demonstrating promising results in international Phase III trials.12345

Is the combination of Eciskafusp Alfa and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been studied in various cancers and generally has an acceptable safety profile. Common side effects include tiredness, loss of appetite, and nausea, while more serious effects can include lung inflammation, liver inflammation, and thyroid issues. However, specific safety data for the combination with Eciskafusp Alfa is not provided in the available research.12356

What makes the drug Atezolizumab unique for cancer treatment?

Atezolizumab is unique because it is a monoclonal antibody that targets PD-L1, a protein that helps cancer cells evade the immune system, thereby enhancing the body's immune response against tumors. It has shown promising results in various cancers, including lung and breast cancer, by improving overall survival rates compared to traditional chemotherapy.12357

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.
See 4 more

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.
See 15 more

Timeline

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

Treatment Details

Interventions

  • Atezolizumab
  • RO7284755
Trial OverviewThe 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.
Participant Groups
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.

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

Find a Clinic Near You

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 profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

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.
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 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.
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 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.
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]

References

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]
Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]
Atezolizumab: First Global Approval. [2019]
Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. [2020]
The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. [2022]