RO7567132 + Atezolizumab for Cancer

Recruiting at 11 trial locations

Overseen By Reference Study ID Number: BP44956 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Disqualifiers: CNS tumors, Second malignancy, Cardiovascular disease, Autoimmune disease, 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

Duration: 12 weeks

180 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 (Tecentriq) for cancer?

Atezolizumab has shown effectiveness in treating advanced bladder cancer, with a 15% response rate in patients whose cancer progressed after chemotherapy and a 24% response rate in those who hadn't received chemotherapy. It has also been approved for use in certain types of breast and lung cancer, demonstrating its potential in treating various cancers. ^{1 2 3 4 5}

Is the combination of RO7567132 and Atezolizumab generally safe for humans?

Atezolizumab, also known as Tecentriq, has been studied in various cancers and is generally considered to have an acceptable safety profile. Common side effects include fatigue, decreased appetite, and nausea, while more serious but less common effects can include lung inflammation, liver inflammation, and thyroid issues. The safety of RO7567132 specifically is not detailed in the provided research. ^{1 2 3 6 7}

What makes the drug RO7567132 + Atezolizumab unique for cancer treatment?

The combination of RO7567132 and Atezolizumab is unique because Atezolizumab 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. This approach is different from traditional chemotherapy as it specifically boosts the immune system to fight cancer cells. ^{1 2 3 4 8}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

Research Team

Clinical trails

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

Adults over 18 with advanced solid tumors, for whom standard treatments failed or aren't suitable. They must be relatively active (ECOG status 0-1), expected to live at least 12 weeks, and able to provide a tumor sample. Participants need good heart, blood, liver, and kidney function and women must not be pregnant.

Inclusion Criteria

My heart, blood, liver, and kidneys are all functioning well.

I can provide a sample of my tumor for the study.

My cancer has spread beyond its original location.

Exclusion Criteria

I have tumors or cancer spread to my brain or spinal cord.

I have had another type of cancer in the last 2 years.

I have a significant liver condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7567132 as a single agent and in combination with atezolizumab to evaluate safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atezolizumab
• RO7567132

Trial Overview The trial is testing RO7567132 alone and combined with Atezolizumab in patients with advanced cancers. It aims to assess the safety of these drugs, how they affect the body (PK/PD), and their initial effectiveness against cancer.

Participant Groups

Group I: Part II: RO7567132 Backfill With Atezolizumab Experimental Treatment 1 Intervention

Group II: Part I: RO7567132 Dose Escalation With or Without Atezolizumab Experimental Treatment 1 Intervention

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

Findings from Research

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 is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

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 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]

The combination of lenalidomide and temsirolimus was well tolerated in a phase I study involving 43 patients with advanced cancers, with no dose-limiting toxicities observed, although 72% experienced reversible grade 3-4 hematologic toxicities.

Clinical benefits were noted, with 2.5% of patients achieving a partial response and 48% having stable disease, particularly in soft tissue sarcoma and adenoid cystic carcinoma, leading to a median overall survival of 7.8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of lenalidomide in combination with temsirolimus in patients with advanced cancer. Ganesan, P., Piha-Paul, S., Naing, A., et al.[2021]

Atezolizumab (Tecentriq) is an FDA-approved treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS), showing a 24% overall response rate in a clinical trial with 49 patients, and a durable response rate of 67% at 6 months and 42% at 12 months.

The treatment has a manageable safety profile, with common severe side effects including musculoskeletal pain (8%) and hypertension (6%), making it a viable option for patients with limited treatment alternatives for this high-risk disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

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, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

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

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. [2022]

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

Phase I clinical trial of lenalidomide in combination with temsirolimus in patients with advanced cancer. [2021]

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

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]

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

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]