ROSE12 + Atezolizumab for Solid Tumor Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Chugai Pharmaceutical
Must not be taking: Investigational therapy, Anti-cancer therapy
Disqualifiers: Cardiovascular, Liver, Autoimmune, CNS, others
No Placebo Group
Breakthrough Therapy
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.
12345Is 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.
12678What 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.
12379Eligibility 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
+5 more
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.
+9 more
Trial 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
Participant Groups
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').
5Treatment groups
Experimental Treatment
Group I: Part E: Expansion part of Phase Ib in patients with selected solid tumorsExperimental Treatment2 Interventions
Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.
Group II: Part D: Biopsy part of Phase IbExperimental Treatment2 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 IbExperimental Treatment2 Interventions
Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.
Group IV: Part B: Biopsy part of Phase IaExperimental Treatment1 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 IaExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
NEXT OncologyFairfax, VA
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Who Is Running the Clinical Trial?
Chugai PharmaceuticalLead Sponsor
References
Atezolizumab: First Global Approval. [2019]Atezolizumab (Tecentriq™)-a monoclonal antibody targeting programmed death ligand 1 (PD-L1 or CD274 antigen)-is being developed by Genentech as treatment for a variety of haematological malignancies and solid tumours. It been approved in the US as a second-line therapy for urothelial carcinoma and is awaiting approval as a second-line therapy for non-small cell lung cancer. This article summarizes the milestones in the development of atezolizumab leading to this first approval for urothelial carcinoma.
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]Atezolizumab (Tecentriq, MPDL3280A; Genentech/Roche) is an FcγR binding-deficient, fully humanized IgG1 mAb designed to interfere with the binding of PD-L1 ligand to its two receptors, PD-1 and B7.1. By blocking the PD-L1/PD-1 immune checkpoint, atezolizumab reduces immunosuppressive signals found within the tumor microenvironment and, consequently, increases T-cell-mediated immunity against the tumor. Atezolizumab has been FDA approved as second-line therapy for advanced bladder cancer. This accelerated approval was based on phase II trial data in patients with metastatic bladder cancer that showed unexpected and durable tumor responses. In subjects whose tumors progressed on first-line platinum-based chemotherapy, the objective response rate was 15%, the complete response rate was 5%, and 1-year overall survival was 36%. In subjects that were chemotherapy naïve and cisplatin ineligible, the objective response rate was 24%, the complete response rate was 7%, and 1-year overall survival was 57%. Better responses were associated with higher PD-L1 expression on the tumor-infiltrating leukocytes. These data suggest that patients with advanced bladder cancer treated with atezolizumab have significantly better response rates and survival than historical controls treated with other second-line regimens. The toxicity profile of atezolizumab is also favorable. Trials are currently assessing whether atezolizumab is effective in earlier bladder cancer stages and in the first-line metastatic setting. Clin Cancer Res; 23(8); 1886-90. ©2016 AACR.
Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]Purpose: Atezolizumab is a programmed death ligand 1 (PDL-1) blocking antibody that was approved for metastatic non-small cell lung cancer (NSCLC) in patients with disease progression. Various studies have been initiated to explore the effectiveness of atezolizumab among different patient cohorts and disease statuses, including as first-line therapy. The purpose of this paper is to identify and summarize the trials that use atezolizumab as a first-line agent in chemotherapy-naïve patients with NSCLC. Methods: A database search was performed on Pubmed, Embase, and Wiley Cochrane Library-Central Register of Controlled Trials to identify clinical trials using atezolizumab as first-line therapy in NSCLC. Additionally, ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) were searched to identify relevant clinical trials. Conference abstracts from the American Society of Clinical Oncology, the European Society for Medical Oncology, and the American Association for Cancer Research were hand-searched. Any trial in which atezolizumab was used as first-line therapy in chemotherapy-naive patients with NSCLC was included. Results: Fifteen studies were ultimately included, all of which are current and ongoing. Of the 15 studies, 5 have reported results. When given in the first-line setting, atezolizumab had higher rates of objective response, progression-free survival, and overall survival, compared to the second and third-line settings. Among the 15 studies, atezolizumab is used as monotherapy (n = 5), in combination with chemotherapy (n = 6), in combination with targeted therapy such as bevacizumab (n = 1), as neoadjuvant/adjuvant therapy (n = 3), in combination with stereotactic body radiation therapy (n = 1), and in combination with or following chemoradiation (n = 1). Conclusion: Available evidence shows promising safety and efficacy with the use of atezolizumab as first-line therapy in NSCLC. Atezolizumab is currently being studied in a variety of treatment settings. If clinical benefits are shown, atezolizumab may deem to be a useful first-line agent in NSCLC.
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]Atezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.
Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. [2022]Atezolizumab (anti-programmed death ligand 1) has demonstrated safety and activity in advanced and metastatic urothelial carcinoma, but its long-term clinical profile remains unknown.
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]On October 18, 2016, the FDA approved atezolizumab (TECENTRIQ; Genentech, Inc.) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose disease progressed during or following platinum-containing chemotherapy. Approval was based on demonstration of clinically meaningful improvements in overall survival (OS) and an acceptable safety profile in two randomized clinical trials (OAK and POPLAR). Median OS in OAK, a phase III trial, was 13.8 months [95% confidence interval (CI), 11.8-15.7] in the atezolizumab arm compared with 9.6 months (95% CI, 8.6-11.2) in the docetaxel arm [hazard ratio (HR) = 0.74; 95% CI, 0.63-0.87; P = 0.0004]. Median OS in POPLAR, a phase II trial, was 12.6 months (95% CI, 9.7-16.0) and 9.7 months (95% CI, 8.6-12.0; HR = 0.69; 95% CI, 0.52-0.92) for the atezolizumab and docetaxel arms, respectively. In patients treated with atezolizumab, the most common (≥20%) adverse reactions were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation; the most common (≥2%) grade 3 to 4 adverse events were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, aspartate aminotransferase increase, alanine aminotransferase increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab included 1.4% incidence each of grade 3 to 4 pneumonitis, hepatitis, colitis, and thyroid disease. Clin Cancer Res; 23(16); 4534-9. ©2017 AACR.
Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]Since the US FDA-approval of the first immune checkpoint inhibitor, anticytotoxic T-lymphocyte antigen-4 monoclonal antibody ipilimumab, for metastatic melanoma on 28 March 2011, another six agents have been granted use among a multitude of tumors, including renal cell cancer, Hodgkin lymphoma, urothelial carcinoma and non-small-cell lung cancer. The first anti-programmed cell death ligand-1 monoclonal antibody to receive the FDA approval, atezolizumab (Tecentriq®), has yielded promising results among international Phase III trials in triple-negative breast cancer and small-cell lung cancer, expanding the field of cancer immunotherapies. Herein, we review the pharmacodynamic and pharmacokinetic properties of atezolizumab, its safety and efficacy data from early clinical trials and summarize data from Phase III IMpassion130 trial, prompting FDA and EMA approval of atezolizumab in metastatic triple-negative breast cancer. Finally, implications for clinical use and ongoing research will be briefly discussed.
The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. [2022]Atezolizumab is a humanized monoclonal antibody against PD-L1 capable of enhancing antitumor immune activity, with a demonstrated activity as single agent in patients with advanced non-small-cell lung cancer (NSCLC).