#1 Clinical Trials Search in Europe

Prs-344

A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of PRS-344/S095012, a novel drug designed to target solid tumors. This phase 1/2 study aims to determine the optimal dosage and assess the drug’s potential in treating advanced and metastatic solid tumors. The trial consists of two parts: a dose escalation phase and an expansion phase, offering hope for patients with difficult-to-treat cancers.

Table of Contents

What is PRS-344/S095012?

PRS-344/S095012 is a new drug being studied for the treatment of advanced or metastatic solid tumors. It is described as a PD-L1x4-1BB bispecific antibody-Anticalin fusion, which is a complex term referring to its unique structure and mechanism of action[1]. To break this down:

  • Bispecific antibody: This means the drug can bind to two different targets at the same time.
  • PD-L1: One target of the drug, which is often found on cancer cells.
  • 4-1BB: Another target of the drug, found on immune cells.
  • Anticalin fusion: A technology used to create the drug, which helps it work more effectively.

How Does It Work?

While the exact mechanism isn’t fully described in the trial information, based on its structure, PRS-344/S095012 likely works by simultaneously targeting cancer cells and activating the immune system. By binding to PD-L1 on cancer cells and 4-1BB on immune cells, it may help the immune system recognize and attack the cancer more effectively[1].

What Conditions Does It Treat?

PRS-344/S095012 is being studied for the treatment of solid tumors. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They can occur in many parts of the body, such as the lungs, breast, colon, and other organs. The trial specifically mentions that it’s for patients with advanced and/or metastatic solid tumors, which means:[1]

  • Advanced: The cancer is in a later stage and has grown larger or spread to nearby tissues.
  • Metastatic: The cancer has spread from its original location to other parts of the body.

Current Clinical Trial

PRS-344/S095012 is currently being studied in a clinical trial. Here are the key points about this trial:[1]

  • Type of trial: It’s a Phase 1/2 trial, which means it’s one of the earlier stages of testing in humans.
  • Purpose: The main goal is to determine the safety and tolerability of the drug.
  • Structure: The trial has two parts:
    1. Dose escalation (Phase 1): This part aims to find the right dose of the drug.
    2. Expansion (Phase 2): This part will further test the drug at the dose determined in Phase 1.
  • Administration: The drug is given as a monotherapy, meaning it’s used alone and not in combination with other treatments.

Safety and Side Effects

A major focus of this trial is to assess the safety of PRS-344/S095012. The researchers will be looking at several aspects of safety:[1]

  • Dose-limiting toxicities (DLTs): These are side effects severe enough to prevent increasing the dose of the drug.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the trial.
  • Serious adverse events (SAEs): These are more severe adverse events.
  • Treatment discontinuation: Cases where patients have to stop taking the drug due to side effects.

The specific side effects are not listed in the trial information, as this is what the study aims to discover. Side effects will be graded according to standardized criteria (NCI CTCAE version 5.0) to assess their severity[1].

Effectiveness Measures

While safety is the primary focus, the trial will also look at how well PRS-344/S095012 works against cancer. They will measure this in several ways:[1]

  • Objective Response (OR): This includes complete response (CR, where all signs of cancer disappear) and partial response (PR, where the tumor shrinks significantly).
  • Duration of Response (DoR): How long the response to treatment lasts.
  • Progression-free Survival (PFS): How long patients live without their cancer getting worse.
  • Overall Survival (OS): How long patients live after starting the treatment.
  • Disease Control (DC): The proportion of patients whose disease improves or stays stable.
  • Time to Response (TTR): How quickly patients respond to the treatment.

Future Prospects

This trial is an important step in the development of PRS-344/S095012. If the results are positive, it could lead to further studies and potentially a new treatment option for patients with advanced solid tumors. However, it’s important to remember that this is an early-stage trial, and more research will be needed to fully understand the drug’s effectiveness and safety[1].

Aspect Details
Study Type Phase 1/2, open-label, multicenter clinical trial
Drug Name PRS-344/S095012
Target Condition Advanced and/or metastatic solid tumors
Primary Objectives Safety, tolerability, and optimal biological dose determination
Secondary Objectives Efficacy measures (e.g., objective response, duration of response, progression-free survival)
Study Duration Up to 24 months
Key Assessments Safety measurements, drug concentrations, anti-drug antibodies, tumor response

FAQ

  • What is PRS-344/S095012? PRS-344/S095012 is a new drug being tested in clinical trials for patients with advanced or metastatic solid tumors. It is a bispecific antibody-anticalin fusion that targets specific proteins in cancer cells.
  • What is the main goal of this clinical trial? The main goal of this trial is to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors. It also aims to find the optimal biological dose (OBD) of the drug.
  • How is the trial structured? The trial has two parts: a dose escalation part (phase 1) and an expansion part (phase 2). The expansion part will begin once the optimal biological dose is determined in phase 1.
  • What are the primary outcomes being measured in this trial? The primary outcomes include safety measurements such as the incidence of dose-limiting toxicities, adverse events, and treatment discontinuation due to side effects. In phase 2, the trial will also measure the objective response rate, which includes complete and partial responses to the treatment.
  • How long will patients be followed in this study? Patients will be followed for up to 24 months through study completion. This allows researchers to assess long-term outcomes such as overall survival and progression-free survival.

Ongoing Clinical Trials on Prs-344

  • Study of PRS-344/S095012 and obinutuzumab combination for patients with solid tumors – First human trial to evaluate safety and effectiveness

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium France Spain

Glossary

  • Solid Tumor: A mass of abnormal cells that forms in organs or tissues. Unlike liquid tumors (such as leukemia), solid tumors are typically confined to a specific area of the body.
  • Bispecific Antibody-Anticalin Fusion: A type of engineered protein that combines two different targeting mechanisms to potentially enhance its effectiveness against cancer cells.
  • Dose Escalation: A process in clinical trials where the amount of drug given to patients is gradually increased to find the safest and most effective dose.
  • Optimal Biological Dose (OBD): The dose of a drug that produces the best balance between effectiveness and side effects in the body.
  • Adverse Event (AE): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Objective Response (OR): A measurable improvement in tumor size or extent, typically categorized as either a complete response (CR) or partial response (PR).
  • RECIST Criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall Survival (OS): The length of time from the start of treatment until death from any cause.
  • Anti-drug Antibodies (ADA): Antibodies produced by the body's immune system in response to a drug, which can potentially affect the drug's effectiveness or safety.

References