What side effects are associated with this type of intervention?

Common treatments for tumors, such as chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, neutropenia, and hair loss. Immunotherapy, including immune checkpoint inhibitors like anti-PD-1 and anti-CTLA-4, may lead to immune-related adverse events such as colitis, dermatitis, and endocrinopathies. Targeted therapies, which act on specific molecular targets, can cause side effects like rash, diarrhea, and liver toxicity. These side effects vary depending on the specific drugs and patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for tumors, particularly focusing on immunotherapies and targeted therapies. Notable examples include immune checkpoint inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo), which target PD-1/PD-L1 pathways to enhance the body's immune response against cancer cells. Additionally, targeted therapies such as vemurafenib (Zelboraf) for BRAF-mutated melanoma and erlotinib (Tarceva) for EGFR-mutated non-small cell lung cancer have been approved. These treatments represent significant advancements in oncology, offering new options for patients with various types of tumors.

What other types of research exist?

Promising novel alternatives to SAR444200 for tumor patients in 2024 include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in non-small cell lung cancer and other tumors. 2) Entrectinib, a targeted therapy for ROS1 fusion-positive non-small-cell lung cancer. 3) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and RET fusion-positive non-small-cell lung cancer. 4) Futibatinib, an FGFR-selective tyrosine kinase inhibitor, for cholangiocarcinoma with FGFR2 fusions/rearrangements. These therapies have demonstrated significant clinical activity and safety in various advanced solid tumors.

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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

No Placebo-Only Group

Summary

This trial is testing a new drug called SAR444200, either alone or with other cancer treatments. It targets adults with advanced cancer who have already received other treatments. The study will check if the drug is safe, how it behaves in the body, and if it helps treat cancer.

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.

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.

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

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

Primary study objectives

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 study objectives

All parts: Assessment of PK parameters: Cmax

All parts: Assessment of PK parameters: Tmax

All parts: Duration of response (DoR)

+5 more

Awards & Highlights

No Placebo-Only Group

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

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

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 tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy, such as immune checkpoint inhibitors (e.g., anti-PD-1 or anti-CTLA-4), enhances the body's immune response against cancer cells, offering a more targeted approach with potentially fewer side effects. Targeted therapies, like tyrosine kinase inhibitors, specifically block molecular pathways essential for tumor growth and survival. These treatments are crucial for tumor patients as they offer various strategies to control tumor progression, improve survival rates, and potentially reduce treatment-related toxicity.

Current trends and future directions in the genetic therapy of human neoplastic disease.