What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, immunotherapy, and targeted therapy, often have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapy, such as PD-1 or PD-L1 inhibitors, may lead to immune-related adverse events like colitis, pneumonitis, hepatitis, and endocrinopathies. Targeted therapies can result in side effects specific to the targeted pathway, such as skin rashes, hypertension, and diarrhea. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of solid tumors, particularly those involving immune checkpoint inhibitors and targeted therapies. For instance, pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various solid tumors including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, targeted therapies like bevacizumab, an anti-VEGF antibody, and tyrosine kinase inhibitors such as sunitinib and pazopanib have been approved for cancers like renal cell carcinoma and soft tissue sarcoma. These treatments, similar to SAR445877, represent advancements in targeting specific pathways and mechanisms in cancer therapy.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: <ol> <li>Regorafenib: A multitargeted kinase inhibitor with demonstrated activity in advanced osteosarcoma and other solid tumors.</li> <li></li> </ol> Cabozantinib: Another multitargeted kinase inhibitor showing efficacy in advanced Ewing sarcoma and osteosarcoma. 3. Pembrolizumab: An immune checkpoint inhibitor used in combination with chemotherapy for various solid tumors, including non-small cell lung cancer. 4. Nivolumab: Another immune checkpoint inhibitor, effective in combination with chemotherapy for esophageal and gastric cancers. 5. Venetoclax: A BCL-2 inhibitor used in combination with other agents for chronic lymphocytic leukemia, showing potential in solid tumors. 6. Lutetium-177-PSMA-617: A radioligand therapy for metastatic castration-resistant prostate cancer, with potential applications in other solid tumors.

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Monoclonal Antibodies

SAR445877 for Advanced 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 from baseline to the end of study (up to 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, SAR445877, for adults with advanced cancers that are hard to treat. The study will find the best amount to use and check if the drug is safe and works well, both alone and with other treatments.

Who is the study for?

Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack suitable standard treatments. Specific groups include those with certain types of lung, stomach, liver cancers, and gastroesophageal junction adenocarcinoma. Participants must have measurable disease and give informed consent.

What is being tested?

SAR445877 is being tested as a solo treatment for various advanced cancers. The trial has two parts: the first to find the best dose given every week or every other week; the second to test safety and early results at two dose levels in specific cancer types.

What are the potential side effects?

As this is an early-phase trial for SAR445877, detailed side effects are not yet fully known but may include typical reactions seen with cancer therapies such as fatigue, nausea, immune-related issues or infusion reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the 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

Therapeutic procedure

Dose escalation: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2

Dose expansion/optimization: Objective response rate (ORR)

Secondary study objectives

Dose escalation & expansion/optimization: Assessment of Cetuximab serum concentration

Dose escalation & expansion/optimization: Assessment of SAR445877 AUC0-T

Dose escalation & expansion/optimization: Assessment of SAR445877 Cmax

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

10Treatment groups

Experimental Treatment

Group I: SAR445877 Expansion/Optimization Phase: Cohort E3 (Part 2B)Experimental Treatment2 Interventions

SAR445877 will be administered IV in combination with cetuximab in patients with colorectal cancer (CRC).

Group II: SAR445877 Expansion/Optimization Phase: Cohort E2 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with colorectal cancer (CRC).

Group III: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with colorectal cancer (CRC).

Group IV: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with immune infiltrated tumor type.

Group V: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VI: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VII: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered IV in patients with hepatocellular carcinoma (HCC).

Group VIII: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered intravenously in patients with non-small cell lung cancer (NSCLC).

Group IX: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered intravenously (IV) in patients with non-small cell lung cancer (NSCLC).

Group X: SAR445877 Escalation Phase (Part 1)Experimental Treatment1 Intervention

SAR445877 monotherapy will be administered intravenously in patients with solid tumors over a 14-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

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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 works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular abnormalities in cancer cells, such as mutations in genes like EGFR or ALK, thereby sparing normal cells and reducing side effects. Immunotherapy, including checkpoint inhibitors like anti-PD-1 or anti-CTLA-4, boosts the body's immune system to recognize and destroy cancer cells. These treatments are crucial for solid tumor patients as they offer different mechanisms to control or eliminate tumors, potentially improving survival and quality of life.

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