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.

← Back to Search

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

Study Summary

This trial will study a new drug to see if it is safe & effective to treat advanced cancers. Up to 240 people will take part.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Therapeutic procedure

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

Dose expansion: Objective response rate (ORR)

Secondary outcome measures

Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1

Dose escalation & expansion Assessment of SAR445877 AUC0-T

Dose escalation & expansion Assessment of SAR445877 Cmax

+6 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: SAR445877 Expansion Phase: Cohort D (Part 2)Experimental Treatment1 Intervention

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

Group II: SAR445877 Expansion Phase: Cohort C (Part 2)Experimental Treatment1 Intervention

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

Group III: SAR445877 Expansion Phase: Cohort B (Part 2)Experimental Treatment1 Intervention

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

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

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

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

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

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 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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,171 Previous Clinical Trials

3,516,367 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

864 Previous Clinical Trials

2,019,832 Total Patients Enrolled

Media Library

SAR445877 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05584670 — Phase 1 & 2

Solid Tumors Research Study Groups: SAR445877 Escalation Phase (Part 1), SAR445877 Expansion Phase: Cohort A (Part 2), SAR445877 Expansion Phase: Cohort B (Part 2), SAR445877 Expansion Phase: Cohort C (Part 2), SAR445877 Expansion Phase: Cohort D (Part 2)

Solid Tumors Clinical Trial 2023: SAR445877 Highlights & Side Effects. Trial Name: NCT05584670 — Phase 1 & 2

SAR445877 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584670 — Phase 1 & 2

~152 spots leftby Jan 2027

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.