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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

Study Summary

This trial will assess the safety and how drugs interact with solid tumor cancer. Tissue samples will be taken to evaluate biomarkers.

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.Check my eligibility

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').See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor

95 Previous Clinical Trials

21,485 Total Patients Enrolled

Sponsor Chugai Pharmaceutical Co.LtdStudy Directorclinical-trials@chugai-pharm.co.jp

1 Previous Clinical Trials

144 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are the extant sites for this experiment?

"MD Anderson Cancer Center in Houston, NEXT Oncology in Fairfax, and National Cancer Center Hospital in Chuo-ku are the top 3 sites currently recruiting patients for this trial. Additionally, 4 more locations are also taking part."

Answered by AI

Are there any slots still available for patient participation in this research?

"The details listed on clinicaltrials.gov indicate that this medical trial is now actively recruiting participants. It was first established on May 24th 2023 and most recently edited September 29th of the same year."

Answered by AI

Could you provide a count of the individuals that are currently participating in this trial?

"Affirmative. Data available on clinicaltrials.gov confirms that this scientific study, which was initialised on May 24th 2023, is in the process of sourcing participants. This requires 219 individuals who are willing to be tested at 4 different medical facilities."

Answered by AI

Has Part A: Dose-escalation been formally recognized by the FDA as part of Phase Ia?

"Given that this is a Phase I trial, which implies limited safety and efficacy information, our team at Power gave Part A: Dose-escalation part of the study a grade of 1 on their safety scale."

Answered by AI

What are the chief aims of this experiment?

"According to Chugai Pharmaceutical, the primary outcome assessed during this trial will be safety and tolerability of ROSE12 when administered alone or alongside atezolizumab. Furthermore, secondary parameters that will be monitored include minimum serum concentration (Cmin) of atezolizumab for PK profile, objective response rate (ORR), and progression-free survival (PFS). These measurements will span a 21 day period from Cycle 1 Day 1 until Cycle 1 Day 21."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

2023. "A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907980.