What side effects are associated with this type of intervention?

Common treatments for solid tumors, including investigational anti-cancer agents like S095029 and immune checkpoint inhibitors like Sym021, often cause side effects such as nausea, vomiting, fatigue, and hematologic toxicities (e.g., neutropenia, anemia). Immune checkpoint inhibitors can also lead to immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which target the PD-1 pathway and have been approved for various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, ipilimumab (Yervoy), which targets CTLA-4, has been approved for melanoma. These drugs work by enhancing the immune system's ability to fight cancer, similar to the investigational agents S095029 and Sym021 being studied for their anti-cancer properties.

What other types of research exist?

Promising alternatives for solid tumor patients include multitargeted kinase inhibitors like regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown some activity in advanced cancers. Additionally, immune checkpoint inhibitors such as nivolumab-relatlimab and pembrolizumab, as well as novel radiopharmaceuticals like samarium-153 lexidronam for bone metastases, are potential options. Clinical trials for these agents are ongoing, and they may offer new therapeutic avenues in 2024.

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S095029 + Sym021 for Colorectal Cancer

Phase 1

Waitlist Available

Led By Nehal Lakhani MD, MD, PhD

Research Sponsored by Institut de Recherches Internationales Servier

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 through study completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs, S095029 and Sym021, to see if they can help treat advanced cancers. The study focuses on patients whose cancers have not responded well to other treatments. Researchers want to find out if these drugs can safely and effectively stop or slow down cancer growth.

Who is the study for?

This trial is for adults with advanced solid tumors, including metastatic HER2+ gastric and colorectal cancers. Participants must have tried standard treatments without success or be intolerant to them. They need good heart, liver, kidney, and blood function and can't have had major surgery recently or suffer from active infections or certain chronic conditions.

What is being tested?

The study tests S095029 alone and combined with Sym021 in patients with various solid tumors. It will expand to test triple combinations involving anti-HER2 therapy (futuximab/modotuximab) specifically in those with metastatic gastric or colorectal cancers.

What are the potential side effects?

While the specific side effects are not listed here, typical reactions may include skin rashes due to prior treatments, issues related to organ functions like the heart (ejection fraction changes), liver (hepatic problems), kidneys (renal function), as well as potential gastrointestinal abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 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

Adverse Events (AEs) (Dose escalation part)

Assessment of antitumor activity using RECIST v1.1 (Dose expansion part)

Incidence of dose limiting toxicities (DLTs) (Dose escalation part)

Secondary study objectives

Clinical Benefit Rate (CBR) (Dose escalation and dose expansion parts)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion 2b: S095029 and Sym021 and futuximab/modotuximabExperimental Treatment1 Intervention

Group II: Dose expansion 2a: S095029 and Sym021 and anti-HER2 therapyExperimental Treatment1 Intervention

Group III: Dose escalation 1b: S95029 and Sym021Experimental Treatment1 Intervention

Group IV: Dose escalation 1a: S95029Experimental Treatment1 Intervention

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 targeted therapies and immune checkpoint inhibitors. Targeted therapies, like tyrosine kinase inhibitors, disrupt specific molecules and pathways essential for cancer cell growth and survival. Immune checkpoint inhibitors, such as those targeting PD-1/PD-L1 or CTLA-4, boost the immune system's ability to attack cancer cells by blocking proteins that suppress immune responses. These mechanisms are vital for solid tumor patients as they enable more personalized and effective treatment strategies, potentially leading to better outcomes and fewer side effects.