What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy agents (paclitaxel, cisplatin, etoposide) and targeted therapies (pazopanib), are associated with side effects like myelosuppression, alopecia, mucosal inflammation, gastrointestinal issues (nausea, vomiting, diarrhea), hypertension, hypothyroidism, fatigue, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, including targeted therapies and immunotherapies. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors used in various solid tumors such as melanoma and renal cell carcinoma. Additionally, bevacizumab, an anti-angiogenic agent, has been approved for use in combination with chemotherapy for certain types of solid tumors, including colorectal and lung cancers. These treatments, similar to those being studied in the ROSE12 trial, focus on enhancing the body's immune response to cancer or inhibiting tumor blood supply.

What other types of research exist?

Promising alternatives to ROSE12 for solid tumor patients include pembrolizumab, nivolumab, and atezolizumab, which are immune checkpoint inhibitors showing efficacy in various solid tumors. Additionally, combination therapies such as pembrolizumab plus axitinib for renal cell carcinoma and nivolumab plus ipilimumab for melanoma have demonstrated significant clinical benefits. These alternatives have been validated in multiple phase II and III trials, offering robust options for treatment in 2024.

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Monoclonal Antibodies

ROSE12 + Atezolizumab for Solid Tumor Cancer

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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').

What are the potential side effects?

Possible side effects include allergic reactions similar to those seen with antibody-based drugs which could range from mild skin reactions to more serious conditions affecting organs due to an overactive immune response. Specific side effects will depend on ROSE12's profile as discovered during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab (Part E)

Safety (All Parts) and tolerability (Part A, B, C and D) of ROSE12 when administered as a single agent and in combination with atezolizumab (Adverse Events)

The area under the concentration time-curve (AUC) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab (All Parts)

+3 more

Secondary study objectives

Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (All Parts)

Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A, B, C and D)

The area under the concentration-time curve (AUC) of atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapy uses drugs that specifically target molecular pathways essential for tumor growth and survival, minimizing damage to normal cells. Immunotherapy enhances the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for solid tumor patients as they help in selecting the most appropriate treatment based on the tumor's specific characteristics and the patient's overall health.

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