RO7567132 + Atezolizumab for Cancer

Not currently recruiting at 18 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment combination for individuals with advanced or spreading solid tumors. It involves two treatments: RO7567132 (an experimental treatment), both alone and with atezolizumab, which is already used in cancer therapy. The researchers aim to determine how these treatments work together and if they can help when standard treatments fail. Individuals with advanced cancer, who have tried other treatments without success, might be suitable for this trial. Participants must provide a tumor sample and have stable overall health. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

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

Research shows that RO7567132 is undergoing tests to determine its safety when used alone and with another drug, atezolizumab, in cancer patients. Early results in animals, such as mice, have been encouraging, but human testing is just beginning.

Atezolizumab, included in this study, already has approval for treating certain types of cancer. However, safety concerns have arisen when combined with other drugs like paclitaxel, indicating that its safety can vary depending on the combination.

Since this trial is in an early phase, the primary goal is to assess the safety and tolerability of these treatments. This involves monitoring for any side effects. If successful at this stage, the treatments might be safe for further testing and potential future use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of RO7567132 and Atezolizumab because it offers a fresh approach to cancer treatment. Unlike traditional therapies that often target cancer cells directly, RO7567132 works by modulating the immune system, potentially enhancing the body's natural ability to fight cancer. Atezolizumab, an established immunotherapy, blocks the PD-L1 protein, which can help prevent cancer cells from evading immune detection. Together, these treatments may provide a more comprehensive immune response against cancer, offering hope for improved outcomes compared to standard chemotherapy or targeted therapies.

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

In this trial, researchers are exploring the combination of RO7567132 with atezolizumab, as both drugs help the immune system fight cancer cells. Participants may receive RO7567132 alone or with atezolizumab. Research has shown that atezolizumab, a type of immunotherapy, can effectively treat some cancers when combined with chemotherapy. Previous studies found that using atezolizumab with chemotherapy improved treatment outcomes for cancer patients. RO7567132 is a newer immunotherapy drug under testing, and early animal studies showed promise, especially for breast cancer. While more research is needed to confirm its effectiveness in people, these treatments could offer new hope for patients with advanced cancers. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical trails

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

I am mostly active and my doctor expects me to live at least 12 more weeks.

Exclusion Criteria

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

I have a significant liver condition.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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, 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]

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, 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06537310

NCT06537310 | A Dose-escalation Study of RO7567132 ... The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/cancer/solid-tumors/a-dose-escalation-study-of-ro7567132-as-single-agent-an-91039.html

Global study to see how safe is RO7567132 as single agent... This study is testing a medicine called RO7567132. It is an immunotherapy that is being developed for the possible treatment of cancer that has spread.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11696331/

Outcomes of Combined Atezolizumab Plus Chemotherapy in ... The objectives of this study were to confirm the treatment outcomes of combined atezolizumab plus chemotherapy, and to identify prognostic factors.

4. aacrmeetingnews.org aacrmeetingnews.org/news/new-drugs-on-the-horizon-sessions-provide-first-look-at-12-new-therapeutics/

New Drugs on the Horizon sessions provide first look at 12 ... In mouse models of breast cancer, RO7567132 ... It is now in a phase I trial that includes a combination with atezolizumab (Tecentriq) PD-L1 ...

5. cancernetwork.com cancernetwork.com/view/atezolizumab-combo-real-world-data-match-clinical-trial-efficacy-in-sclc

Atezolizumab Combo Real-World Data Match Clinical Trial ... Real-world atezolizumab plus chemotherapy data demonstrated similar efficacy compared with what the phase 3 IMpower133 trial showed.

6. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-issues-alert-about-efficacy-and-potential-safety-concerns-atezolizumab-combination-paclitaxel

FDA issues alert about efficacy and potential safety ... FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer.