RO7759065 + Atezolizumab for Cancer

Recruiting at 7 trial locations

Overseen By Reference Study ID Number: GO45296 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Pregnancy, HIV, 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

310 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.

Will I have to stop taking my current medications?

The trial requires that you stop any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, at least 3 weeks before starting the study treatment. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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 couldn't receive certain chemotherapy. It is also approved for use in non-small cell lung cancer and triple-negative breast cancer, showing promising results in clinical trials. ^{1 2 3 4 5}

Is the combination of RO7759065 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 fatigue, decreased appetite, and nausea, while more serious effects like pneumonia and liver inflammation occur less frequently. Always consult with a healthcare provider for personalized advice. ^{1 3 5 6 7}

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 boosting the body's immune response against tumors. It has shown promising results in improving survival rates in certain cancers like bladder and lung cancer, especially in patients who have not responded to traditional chemotherapy. ^{1 3 4 6 7}

Eligibility Criteria

This trial is for patients with advanced, recurrent, or metastatic solid tumors that can't be cured. Participants must meet certain health standards and may have had previous treatments. Specific criteria will determine who can join.

Inclusion Criteria

My blood and organs are functioning well.

Life expectancy at least 12 weeks

Availability of representative tumor specimens required for patients in select cohorts

Exclusion Criteria

I have active hepatitis B, C, or tuberculosis.

I have had a severe reaction to previous cancer immunotherapy.

I haven't had any cancer treatment, including chemotherapy, in the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ia: Dose Escalation

Evaluation of safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent

Phase Ia: Expansion

Further evaluation of RO7759065 as a single agent in an expanded cohort

Phase Ib: Dose Escalation

Evaluation of safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 in combination with atezolizumab

Phase Ib: Expansion

Further evaluation of RO7759065 in combination with atezolizumab in an expanded cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Atezolizumab
• RO7759065

Trial Overview The study tests RO7759065 alone (Phase Ia) and combined with Atezolizumab (Phase Ib) to assess safety, dosage levels, body response, immune reaction, and initial effectiveness in shrinking or controlling tumor growth.

Participant Groups

Group I: Phase Ib: Expansion Experimental Treatment 2 Interventions

Group II: Phase Ib: Dose Escalation Experimental Treatment 2 Interventions

Group III: Phase Ia: Expansion Experimental Treatment 1 Intervention

Group IV: Phase Ia: Dose Escalation 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?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

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 combined with chemotherapy (ABCP or ACnP) has been shown to significantly improve progression-free survival (PFS) and overall survival (OS) in chemotherapy-naïve patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), based on the IMpower150 and IMpower130 studies.

Both treatment regimens (ABCP and ACnP) demonstrated manageable safety profiles, with most immune-related side effects being mild to moderate and reversible, making them promising first-line options for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. Dhillon, S., Syed, YY.[2020]

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, 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, 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 (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]

References

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

Atezolizumab: First Global Approval. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. [2020]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

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]