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Sym024

A groundbreaking clinical trial is underway to investigate the potential of Sym024, an anti-CD73 antibody, in treating advanced solid tumor malignancies. This study aims to evaluate the safety and effectiveness of Sym024 both as a standalone treatment and in combination with Sym021, an anti-PD-1 antibody. The trial focuses on patients with metastatic cancer and solid tumors, offering hope for new treatment options in the fight against these challenging conditions.

Table of Contents

What is SYM024?

SYM024 is a new drug being studied for the treatment of advanced solid tumor malignancies, which are cancers that form solid masses in the body[1]. It is classified as an anti-CD73 antibody, which means it’s a type of protein designed to target and block a specific molecule called CD73 found on some cancer cells[1].

How Does SYM024 Work?

While the exact mechanism of action is not fully detailed in the clinical trial information, anti-CD73 antibodies like SYM024 typically work by blocking the CD73 molecule on cancer cells. CD73 is known to help cancer cells evade the immune system, so by blocking it, SYM024 may help the body’s immune system recognize and attack the cancer more effectively[1].

What Conditions Does SYM024 Treat?

SYM024 is being studied for the treatment of metastatic cancer and solid tumors[1]. Metastatic cancer refers to cancer that has spread from its original site to other parts of the body. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas, and can occur in various parts of the body such as the lungs, breast, colon, or prostate.

Clinical Trial Overview

The clinical trial for SYM024 is designed to evaluate its safety, tolerability, and preliminary effectiveness in treating advanced solid tumor malignancies[1]. The study is divided into several parts:

  • Part 1: This phase assesses SYM024 when used alone (monotherapy) to determine the highest dose that can be given safely (known as the maximum tolerated dose or MTD)[1].
  • Part 2: This phase evaluates SYM024 when used in combination with another drug called SYM021[1].
  • Part 2a: In this phase, patients receive SYM024 alone for the first treatment cycle, followed by a combination of SYM024 and SYM021 in subsequent cycles[1].

Combination Therapy with SYM021

The clinical trial also explores the potential benefits of combining SYM024 with another drug called SYM021[1]. SYM021 is described as a humanized anti-PD-1 antibody. PD-1 is a protein on immune cells that acts as a “checkpoint” to prevent the immune system from attacking the body’s own tissues. Some cancer cells can exploit this checkpoint to avoid being attacked by the immune system. By blocking PD-1, SYM021 may help the immune system recognize and attack cancer cells more effectively[1].

Safety and Efficacy Evaluation

The primary goal of the clinical trial is to assess the safety and tolerability of SYM024, both when used alone and in combination with SYM021[1]. Researchers will be monitoring for any side effects or adverse events that patients may experience during the treatment.

In addition to safety, the trial will also evaluate how effective SYM024 is in treating cancer. This includes measuring:

  • Objective response (OR) or stable disease (SD): This refers to whether the tumor shrinks or stops growing in response to the treatment[1].
  • Time to progression (TTP): This measures how long it takes for the cancer to start growing again after treatment[1].

Potential Benefits for Patients

While it’s important to note that SYM024 is still in the experimental stage, it represents a potentially promising new approach to treating advanced solid tumors and metastatic cancer[1]. By targeting CD73 and potentially enhancing the body’s immune response against cancer, SYM024 may offer hope for patients who have not responded well to other treatments.

However, as with all experimental treatments, it’s crucial to remember that more research is needed to fully understand the benefits and risks of SYM024. Patients interested in this treatment should discuss it thoroughly with their healthcare providers to determine if participating in a clinical trial might be appropriate for their individual situation.

Aspect Details
Study Drug Sym024 (anti-CD73 antibody)
Combination Drug Sym021 (anti-PD-1 antibody)
Target Condition Advanced solid tumor malignancies, metastatic cancer
Study Design Phase 1, open-label, multicenter trial
Primary Objectives Assess safety, tolerability, and preliminary antineoplastic activity
Treatment Schedule Every two weeks (Q2W)
Key Outcomes Measured Adverse events, maximum tolerated dose, objective response, time to progression, pharmacokinetics
Secondary Assessments Immunogenicity, tumor response (RECIST v1.1 and iRECIST)

FAQ

  • What is the main purpose of this clinical trial? The primary purpose of this study is to determine if Sym024 is safe and tolerable when used alone and in combination with Sym021 in patients with advanced solid tumor malignancies.
  • How is the trial structured? The trial is divided into multiple parts. Part 1 assesses Sym024 as a monotherapy, Part 2 evaluates Sym024 in combination with Sym021, and Part 2a examines Sym024 alone for one cycle before combining it with Sym021 in subsequent cycles.
  • What are Sym024 and Sym021? Sym024 is an anti-CD73 antibody, while Sym021 is a humanized anti-PD-1 antibody. Both are being studied for their potential in treating advanced solid tumors.
  • How often are the treatments administered? The treatments are administered on a Q2W schedule, which means every two weeks.
  • What are some of the outcomes being measured in this trial? The trial measures various outcomes, including the safety and tolerability of the treatments, potential immune responses, objective tumor responses, time to disease progression, and several pharmacokinetic parameters such as drug concentration in the body over time.

Ongoing Clinical Trials on Sym024

  • Study of SYM024, SYM023, and SYM025 in Adults with Advanced Non-Small Cell Lung Cancer (NSCLC) with High PD-L1 Expression

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Hungary Italy Romania +1

Glossary

  • Solid Tumor Malignancies: Cancers that form solid masses of tissue, as opposed to blood cancers. These can occur in various parts of the body such as the lungs, breast, colon, or prostate.
  • Monotherapy: A treatment approach using a single drug or therapy.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug or treatment that does not cause unacceptable side effects.
  • Maximum Administered Dose (MAD): The highest dose of a drug given in a study, which may be lower than the maximum tolerated dose.
  • Cycle: A period of treatment followed by a period of rest. Cycles are repeated at regular intervals.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug or treatment that are serious enough to prevent an increase in dose or require a decrease in dose.
  • Q2W Schedule: A dosing schedule where treatment is given every two weeks.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • Anti-Drug Antibody (ADA): Antibodies produced by the immune system against a therapeutic drug, which can potentially reduce the drug's effectiveness.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • iRECIST: Immunotherapeutics Response Evaluation Criteria in Solid Tumors, an adaptation of RECIST for immunotherapy treatments.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Anti-CD73 Antibody: An antibody designed to target and block CD73, a protein found on some cancer cells that can suppress immune responses.
  • Anti-PD-1 Antibody: An antibody that targets the PD-1 protein on immune cells, helping to boost the immune system's ability to fight cancer.

References

  1. https://clinicaltrials.gov/study/NCT04672434