ROSE12 + Atezolizumab for Solid Tumor Cancer

Recruiting at 3 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Must not be taking: Investigational therapy, Anti-cancer therapy

Disqualifiers: Cardiovascular, Liver, Autoimmune, CNS, 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

219 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ROSE12 in patients with advanced or spreading solid tumors. It aims to find a safe dose, understand how the drug works in the body, and see how it interacts with other cancer treatments.

Will I have to stop taking my current medications?

The trial requires that you stop any investigational or anti-cancer therapy at least 28 days before starting the study drug. The protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Atezolizumab for solid tumor cancer?

Atezolizumab has shown effectiveness in treating advanced bladder cancer and non-small cell lung cancer, with improved response rates and survival compared to other treatments. It works by boosting the body's immune response against cancer cells, and has been approved for use in these cancers based on clinical trial results. ^{1 2 3 4 5}

Is the combination of ROSE12 and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been approved for several cancers and has shown an acceptable safety profile in clinical trials. Common side effects include fatigue, decreased appetite, and nausea, while more serious effects can include lung inflammation and liver issues. However, specific safety data for the combination with ROSE12 is not available. ^{1 2 6 7 8}

What makes the drug ROSE12 + Atezolizumab unique for treating solid tumor cancer?

The combination of ROSE12 and Atezolizumab is unique because Atezolizumab is a monoclonal antibody that blocks PD-L1, enhancing the immune system's ability to fight cancer cells, and it has shown promising results in other cancers like bladder and lung cancer. This combination may offer a novel approach for solid tumors by potentially improving immune response against the cancer. ^{1 2 3 7 9}

Research Team

Sponsor Chugai Pharmaceutical Co.Ltd

Principal Investigator

[e-mail]

Eligibility Criteria

Adults (18+) with advanced solid tumors, who have tried standard treatments without success or for whom no standard treatment exists. They must be in relatively good health otherwise (ECOG PS 0 or 1), have a life expectancy of at least 12 weeks, and be able to provide tumor samples. People with severe allergies to certain antibodies, recent cancer treatments, unresolved side effects from past therapies (except hair loss and some hormone issues), brain metastases needing treatment, significant heart/liver disease, history of severe immune reactions to immunotherapy, uncontrolled pain/effusions/autoimmune diseases or another cancer within the last five years cannot join.

Inclusion Criteria

I am fully active or can carry out light work.

I have a tumor that can be easily reached for a biopsy.

Life expectancy >= 12 weeks

Exclusion Criteria

I have a brain tumor or cancer spread to my brain that needs treatment.

I have ongoing side effects from cancer immunotherapy, except for stable hormone issues, vitiligo, or hair loss.

I have previously been treated with a drug that targets Treg cells.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive ROSE12 as a single agent and in combination with atezolizumab at escalated doses to determine the maximum tolerated dose and recommended dose.

21 days per cycle

Multiple visits per cycle for dose administration and monitoring

Biopsy

Serial biopsies are conducted to evaluate biomarkers while patients receive ROSE12 and atezolizumab.

Concurrent with dose-escalation

Expansion

Participants receive ROSE12 and atezolizumab at the recommended dose to further evaluate safety and preliminary anti-tumor activity.

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Up to 43 months

Treatment Details

Interventions

• Atezolizumab
• ROSE12

Trial Overview The trial is testing ROSE12's safety and how it moves through the body both alone and combined with other anti-tumor agents like Atezolizumab in patients with solid tumors. It has three parts: finding the right dose ('dose-escalation'), checking biomarkers ('biopsy part'), and offering it to more people once safe doses are found ('expansion part').

Participant Groups

Group I: Part E: Expansion part of Phase Ib in patients with selected solid tumors Experimental Treatment 2 Interventions

Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.

Group II: Part D: Biopsy part of Phase Ib Experimental Treatment 2 Interventions

Serial biopsy will be conducted with patients who will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

Group III: Part C: Dose-escalation part of Phase Ib Experimental Treatment 2 Interventions

Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

Group IV: Part B: Biopsy part of Phase Ia Experimental Treatment 1 Intervention

Serial biopsy will be conducted with patients who will receive ROSE12 as a IV infusion at escalated doses.

Group V: Part A: Dose-escalation part of Phase Ia Experimental Treatment 1 Intervention

Patients will receive ROSE12 as a IV infusion at escalated doses.

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?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical 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, a PD-L1 blocking antibody, shows higher rates of objective response, progression-free survival, and overall survival when used as a first-line therapy in chemotherapy-naïve patients with metastatic non-small cell lung cancer (NSCLC), compared to its use in later treatment lines.

The review included 15 ongoing studies, with 5 reporting results, indicating that atezolizumab is being explored in various treatment combinations and settings, suggesting its potential as a versatile first-line treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. Ryu, R., Ward, KE.[2023]

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Atezolizumab, an anti-PD-L1 therapy, showed long-term safety and efficacy in patients with metastatic urothelial carcinoma, with a median follow-up of 37.8 months and a low incidence of severe treatment-related adverse events (9%).

The treatment resulted in a 26% objective response rate, with a median duration of response of 22.1 months, and median overall survival of 10.1 months, particularly benefiting patients with higher PD-L1 expression on immune cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. Petrylak, DP., Powles, T., Bellmunt, J., et al.[2022]

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 (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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]

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

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]

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

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. [2022]

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

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

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

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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