RO7502175 + Atezolizumab for Advanced Cancers

Recruiting at35 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Genentech, Inc.

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: HIV, Hepatitis B/C, Autoimmune, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, RO7502175, alone and with atezolizumab, in adults with advanced or spreading cancers. It aims to see if these treatments can safely and effectively fight cancer.

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.

What data supports the effectiveness of the drug Atezolizumab for advanced cancers?

Atezolizumab has shown effectiveness in treating advanced bladder cancer and non-small cell lung cancer, with studies indicating improved survival rates and tumor responses compared to other treatments. It works by boosting the body's immune response against cancer cells, and its safety profile is generally favorable. ^{1 2 3 4 5}

Is the combination of RO7502175 and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been studied for safety in various cancers, including bladder cancer and non-small cell lung cancer. It has a favorable safety profile, meaning it is generally well-tolerated by patients, with side effects that are manageable. However, specific safety data for the combination with RO7502175 is not provided in the available research. ^{2 3 5 6 7}

What makes the drug RO7502175 + Atezolizumab unique for advanced cancers?

The drug combination of RO7502175 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 3 4 5 6}

Research Team

Eligibility Criteria

This trial is for adults with certain advanced solid tumors who have a good performance status, measurable disease, and a life expectancy of at least 12 weeks. They must not be pregnant or breastfeeding, have untreated brain metastases, recent cancer treatments, active hepatitis B/C or tuberculosis, HIV infection, autoimmune diseases or live vaccine administration within the last month.

Inclusion Criteria

I can provide a sample of my tumor for testing.

Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Active or history of autoimmune disease

I haven't had a live vaccine in the last 4 weeks.

Prior allogeneic stem cell or organ transplantation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ia: Dose Escalation

Participants receive escalating doses of RO7502175 as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Variable, based on disease progression

1 visit every 21 days

Phase Ia: Expansion

Participants receive a recommended dose of RO7502175 as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Variable, based on disease progression

1 visit every 21 days

Phase Ib: Dose Escalation

Participants receive escalating doses of RO7502175 in combination with a fixed dose of atezolizumab as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Variable, based on disease progression

1 visit every 21 days

Phase Ib: Expansion

Participants receive a recommended dose of RO7502175 in combination with a fixed dose of atezolizumab or pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Variable, based on disease progression

1 visit every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• RO7502175 (Other)

Trial Overview The study tests RO7502175 alone and combined with Atezolizumab in patients with various solid tumors. It's conducted in two parts: first to find the right dose (dose escalation) and then to see how well it works at that dose (dose expansion).

Participant Groups

Group I: Phase Ib: Expansion Experimental Treatment 3 Interventions

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

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

Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group III: Phase Ia: Expansion Experimental Treatment 1 Intervention

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group IV: Phase Ia: Dose Escalation Experimental Treatment 1 Intervention

Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

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, 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 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 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 (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]

In a real-world study of 1002 patients with previously treated non-small cell lung cancer (NSCLC), atezolizumab showed an 18-month overall survival rate of 41.1%, confirming its effectiveness outside of clinical trial settings.

The safety profile was acceptable, with an overall adverse event rate of 43.9% and immune-related adverse events at 19.0%, but caution is advised for patients with poorer performance status (ECOG ≥ 2), as they had a significantly lower survival rate of 14.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL). Miura, S., Nishio, M., Akamatsu, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. France pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. [2020]

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

Atezolizumab: First Global Approval. [2019]

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

Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL). [2023]