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Gen1047

A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of GEN1047, a new drug designed to target malignant solid tumors. This first-in-human study combines Phase I and Phase II trials to assess the drug’s potential in treating various types of cancer, including breast, endometrial, ovarian, and squamous non-small-cell lung cancer. The trial aims to determine the optimal dosage and explore GEN1047’s ability to combat these challenging cancers.

Table of Contents

What is GEN1047?

GEN1047 is a new investigational drug being developed by Genmab for the treatment of certain types of solid tumors. It is currently being studied in a first-in-human clinical trial, which means it’s the first time this drug is being tested in people[1]. GEN1047 is administered as a solution for infusion, which means it’s given directly into the bloodstream through an intravenous (IV) line[1].

The drug is classified as a protein-based treatment, specifically targeting molecules called CD3 and B7H4. These molecules play important roles in the immune system and on cancer cells[1]. By targeting these molecules, GEN1047 may help the body’s immune system to fight against cancer cells more effectively.

What conditions does GEN1047 aim to treat?

GEN1047 is being investigated for the treatment of malignant solid tumors. Specifically, the clinical trial is focusing on patients with the following types of cancer[1]:

  • Breast cancer: A cancer that forms in the cells of the breasts
  • Endometrial cancer: A type of cancer that begins in the lining of the uterus (endometrium)
  • Ovarian cancer: Cancer that begins in the ovaries
  • Squamous non-small-cell lung cancer (NSCLC-SCC): A specific type of lung cancer that affects the flat cells that line the inside of the airways in the lungs

These cancers are being studied in patients with advanced (unresectable) or metastatic disease, which means the cancer has spread to other parts of the body or cannot be completely removed by surgery[1].

Current Clinical Trial Information

The ongoing clinical trial for GEN1047 is a Phase I/II study. This means it combines the initial safety testing of the drug (Phase I) with early effectiveness testing (Phase II) in a single study[1]. The trial is divided into two main parts:

  1. Dose Escalation Part: This part aims to find the safest and most effective dose of GEN1047.
  2. Dose Expansion Part: This part will further test the chosen dose in more patients to gather more data on its effectiveness and safety.

Trial Objectives

The main goals of this clinical trial are[1]:

  • To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of GEN1047. These are the highest doses that can be given safely.
  • To find the recommended Phase 2 dose (RP2D), which is the dose that will be used in future larger studies.
  • To understand the safety profile of GEN1047, including any side effects.
  • To evaluate how well GEN1047 works against tumors (its antitumor activity).
  • To study how the drug moves through and is processed by the body (pharmacokinetics).
  • To check if the body develops antibodies against the drug (immunogenicity).

Who can participate in the trial?

The trial has specific criteria for who can participate. Some key inclusion criteria are[1]:

  • Patients must have a confirmed diagnosis of one of the solid tumors mentioned earlier.
  • The cancer must have either come back after previous treatment or not responded to standard treatments.
  • Patients must have at least one tumor that can be measured.
  • Patients must be in relatively good overall health, with an ECOG performance status of 0 or 1. This means they should be able to carry out all or most daily activities on their own.
  • Patients must be at least 18 years old.
  • For some parts of the study, only female patients with breast cancer are eligible.

Who cannot participate in the trial?

Some key reasons why a person might not be able to participate in the trial include[1]:

  • Having significant heart problems in the past 6 months
  • Having new or worsening brain metastases (cancer that has spread to the brain) or spinal cord compression
  • Having a history of bowel obstruction related to their cancer
  • Having received previous treatment targeting CD3 and/or B7H4
  • Having current or past lung inflammation (pneumonitis) related to drugs or radiation therapy

What will be measured in the trial?

The trial will measure several outcomes to assess the safety and effectiveness of GEN1047[1]:

  • Dose-limiting toxicities (DLTs): These are side effects that are severe enough to prevent increasing the dose further.
  • Adverse events (AEs): Any unfavorable medical occurrences during the trial.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of response (DOR): How long the cancer remains controlled after it responds to treatment.
  • Progression-free survival (PFS): How long patients live without their cancer getting worse.
  • Overall survival (OS): How long patients live overall.
  • Pharmacokinetic (PK) parameters: Measurements of how the drug moves through and is processed by the body.
  • Anti-drug antibody (ADA) response: Whether the body develops antibodies against GEN1047.

This clinical trial represents an important step in the development of GEN1047 as a potential new treatment for certain types of solid tumors. As with all experimental treatments, it’s important to remember that the safety and effectiveness of GEN1047 are still being studied, and more research is needed before it could potentially become an approved treatment.

Aspect Details
Trial Name First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors
Drug GEN1047
Target Conditions Malignant solid tumors (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer)
Trial Structure Dose Escalation Part and Dose Expansion Part
Primary Objectives Determine maximum tolerated dose, characterize safety profile, evaluate antitumor activity
Key Eligibility Criteria Adults with confirmed solid tumors, no further standard therapy options, measurable lesions
Main Endpoints Dose-limiting toxicities, adverse events, objective response rate
Administration Intravenous infusion

FAQ

  • What is GEN1047? GEN1047 is a new drug being tested for the treatment of malignant solid tumors. It is administered intravenously and is designed to target specific proteins in cancer cells.
  • What types of cancer does this trial focus on? The trial focuses on several types of solid tumors, including breast cancer, endometrial cancer, ovarian cancer, and squamous non-small-cell lung cancer (NSCLC-SCC).
  • Who is eligible to participate in this trial? Eligible participants are adults with confirmed solid tumors who have either not responded to standard treatments or have no further standard treatment options available. Specific criteria vary for different parts of the trial.
  • What are the main objectives of the trial? The main objectives are to determine the safe and effective dose of GEN1047, evaluate its safety profile, and assess its potential anti-tumor activity in patients with solid tumors.
  • How is the effectiveness of GEN1047 measured in this trial? The effectiveness is primarily measured by objective response rate (ORR) based on RECIST v1.1 criteria, which evaluates tumor shrinkage. Other measures include duration of response, time to response, and disease control rate.

Ongoing Clinical Trials on Gen1047

  • A Study of GEN1047 in Patients with Solid Tumors: First Time Use in Humans

    Not recruiting

    2 1 1
    Investigated drugs:
    Belgium Denmark France Italy The Netherlands Poland +1

Glossary

  • Malignant Solid Tumor: A type of cancer that forms a mass of tissue and does not contain cysts or liquid areas. These tumors can occur in various parts of the body and are considered malignant when they can spread to other areas.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in further studies to evaluate its effectiveness in treating a specific condition.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment based on changes in tumor size.
  • Pharmacokinetic (PK) Profile: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body. In drug trials, it's important to check if the body develops antibodies against the drug.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS): A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.

References

  1. http://clinicaltrials.eu/trial/56499/