RO7759065 + Atezolizumab for Cancer

Not currently recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with incurable solid tumors. Researchers aim to assess the safety and effectiveness of a drug called RO7759065, both alone and in combination with atezolizumab (Tecentriq, an immunotherapy drug). The trial seeks participants with advanced or recurrent cancer who have a life expectancy of at least 12 weeks. Participants must not have recently undergone certain treatments or had specific infections. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

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

Research has shown that atezolizumab, a drug used to treat various cancers, is generally safe. People often experience side effects like tiredness and nausea, but these are usually manageable. The FDA has approved atezolizumab for certain cancer treatments, indicating its safety for humans.

In contrast, less information is available about RO7759065 because it is a newer treatment. The current study is in its early stages, and researchers are still learning about its tolerability. This phase focuses on safety, so researchers carefully monitor and assess any serious side effects. The study was temporarily paused to review new data, a standard procedure to ensure participant safety.

In summary, while atezolizumab is well-understood, the combination with RO7759065 is still under safety evaluation. Researchers closely monitor trial participants to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of RO7759065 and Atezolizumab for cancer treatment because it offers a novel approach by enhancing the immune system's ability to fight cancer. Unlike traditional chemotherapy, which directly targets cancer cells, this duo leverages Atezolizumab, an immune checkpoint inhibitor, to block the PD-L1 protein, helping immune cells recognize and attack tumors more effectively. RO7759065, a new agent, is designed to potentially enhance this immune response further, offering a unique mechanism of action. This innovative strategy could lead to more effective and durable responses in cancer patients compared to current standards of care.

What evidence suggests that this trial's treatments could be effective for solid tumor malignancies?

Research has shown that atezolizumab can effectively treat certain cancers. For instance, it has benefited about 15% of patients with advanced bladder cancer whose condition worsened after chemotherapy. Atezolizumab has also extended the lives of people with metastatic non-small cell lung cancer (NSCLC). When combined with chemotherapy, it has shown promise for patients with a widespread form of small cell lung cancer. This trial studies the combination of atezolizumab and RO7759065 to assess their effectiveness together. Although RO7759065 is newer and lacks extensive data, there is hope that this combination could provide new options for patients with hard-to-treat cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

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.

My cancer is advanced, has come back, or spread and cannot be cured.

Life expectancy at least 12 weeks

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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, 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, 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06488716

NCT06488716 | A Study to Evaluate the Safety, ... A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally ...

2. withpower.com withpower.com/trial/phase-1-tumors-solid-7-2024-57bb3

RO7759065 + Atezolizumab for Cancer · Info for Participants Atezolizumab has shown effectiveness in treating advanced bladder cancer, with a 15% response rate in patients whose cancer progressed after chemotherapy and a ...

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

Atezolizumab Combo Real-World Data Match Clinical Trial ... Atezolizumab (Tecentriq) plus carboplatin and etoposide demonstrated clinical practice efficacy in patients with extensive-stage small cell lung cancer (ES- ...

5. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... TECENTRIQ helped people with a type of metastatic non-small cell lung cancer (NSCLC) live longer. TECENTRIQ was studied in 4 clinical trials with over 2000 ...

6. tecentriq-hcp.com tecentriq-hcp.com/metastatic-nsclc/side-effects/important-safety-information.html

Important Safety Information | TECENTRIQ® (atezolizumab) Find important safety information for TECENTRIQ® (atezolizumab), a treatment option for metastatic non-small cell lung cancer (NSCLC). See full safety for ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf

TECENTRIQ® (atezolizumab) injection, for intravenous use The safety of TECENTRIQ in combination with bevacizumab was evaluated in IMbrave150, a multicenter, international, randomized, open-label trial in patients ...

8. tecentriq.global tecentriq.global/home/safety-profile.html

Safety profile - tecentriq Review the safety profile of TECENTRIQ monotherapy and combination therapy in clinical trials, including the most commonly reported adverse reactions.