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Monoclonal Antibodies

SAR444200 + Atezolizumab for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Sanofi

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 baseline to end of study (up to 2 years)

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

Adults with advanced solid tumors that have progressed after standard treatments or for whom no effective standard treatment exists. Specifically, it includes those with metastatic liver cancer (HCC) or non-liver solid tumors, and a subset with metastatic lung cancer (NSCLC). Participants must be able to consent and have measurable disease; however, they can't join if they have certain heart conditions, active infections like HIV or hepatitis B/C, severe autoimmune diseases, recent live vaccines, specific lung conditions, poor performance status, certain liver scores (for HCC), brain metastases, organ transplants history of severe immune-related side effects from previous cancer treatments.Check my eligibility

What is being tested?

The trial is testing SAR444200 alone or combined with Atezolizumab in adults with advanced cancers. It's an early-stage study to check the safety of different doses (Phase 1) and see how well the drugs work together (Phase 2). The goal is also to understand how the body processes these drugs and their impact on tumor growth.See study design

What are the potential side effects?

Potential side effects include typical reactions related to immunotherapy such as inflammation in various organs which might mimic symptoms of other diseases. There could also be infusion reactions where the body reacts adversely during drug administration. Since this is a first-in-human study for SAR444200-based regimens specifically designed for people who've had prior treatments fail them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study (up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of study (up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (up to 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1A and 1B: Number of participants with Adverse Events (AEs)

Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs)

Part 2A: Objective Response Rate (ORR)

Secondary outcome measures

All parts: Assessment of PK parameters: Cmax

All parts: Assessment of PK parameters: Tmax

All parts: Duration of response (DoR)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)Experimental Treatment2 Interventions

SAR444200 in combination with atezolizumab will be administered as intravenous injection in participants with GPC3+ solid tumors over a 21-day cycle

Group II: SAR444200 - Dose Expansion Phase (Part 2A)Experimental Treatment1 Intervention

SAR444200 will be administered as intravenous injection in participants with GPC3+ NSCLC over a 21-day cycle

Group III: SAR444200 - Dose Escalation Phase (Part 1A)Experimental Treatment1 Intervention

SAR444200 will be administered as intravenous injection as monotherapy in participants with GPC3+ solid tumors over a 21-day cycle

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?

SanofiLead Sponsor

2,165 Previous Clinical Trials

3,515,196 Total Patients Enrolled

3 Trials studying Tumors

289 Patients Enrolled for Tumors

Clinical Sciences & OperationsStudy DirectorSanofi

863 Previous Clinical Trials

2,020,062 Total Patients Enrolled

1 Trials studying Tumors

59 Patients Enrolled for Tumors

Media Library

SAR444200 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05450562 — Phase 1 & 2

Tumors Research Study Groups: SAR444200 - Dose Escalation Phase (Part 1A), SAR444200 - Dose Expansion Phase (Part 2A), SAR444200 and Atezolizumab combination therapy - Dose Escalation Phase (Part 1B)

Tumors Clinical Trial 2023: SAR444200 Highlights & Side Effects. Trial Name: NCT05450562 — Phase 1 & 2

SAR444200 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05450562 — Phase 1 & 2

Frequently Asked Questions

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

What is the estimated enrollment rate in this trial?

"Affirmative, according to clinicaltrials.gov this medical trial is currently recruiting patients. It was posted on September 20th 2022 and updated lastly on October 17th 2022. The study requires 106 participants from 2 locations to complete it."

Answered by AI

Are there available slots for this clinical experiment?

"Affirmative. Evident from clinicaltrials.gov, this research program is actively recruiting participants. The study commenced on September 20th 2022 and was most recently revised on October 17th 2022 with the goal of enrolling 106 individuals at two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

2022. "Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05450562.

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