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Humanised Igg1 Monoclonal Antibody Against Cd152

Recent clinical trials are exploring the potential of ONC-392, a new drug containing Humanised IgG1 Monoclonal Antibody Against CD152, in treating metastatic non-small cell lung cancer (NSCLC). These studies aim to compare the effectiveness and safety of ONC-392 with the standard treatment, docetaxel, in patients whose cancer has progressed after receiving PD-1/PD-L1 inhibitor therapy. The trials focus on important outcomes such as overall survival, tumor response, and progression-free survival, offering new hope for patients with this challenging form of cancer.

Table of Contents

What is ONC-392?

ONC-392 is a new medication being studied for the treatment of advanced lung cancer. It is classified as a humanised IgG1 monoclonal antibody that targets a protein called CD152[1]. In simpler terms, ONC-392 is a specially designed antibody (a type of protein) that can recognize and attach to a specific target in the body.

How does ONC-392 work?

ONC-392 works by targeting CD152, also known as CTLA-4. This protein plays a role in regulating the immune system. By binding to CD152, ONC-392 aims to enhance the body’s immune response against cancer cells[1]. This approach is part of a type of treatment called immunotherapy, which helps the body’s own immune system fight cancer.

What condition does ONC-392 treat?

ONC-392 is being studied for the treatment of metastatic non-small cell lung cancer (NSCLC)[1][2]. Metastatic means the cancer has spread from the lungs to other parts of the body. This medication is specifically being tested in patients whose cancer has progressed after previous treatment with other immunotherapy drugs called PD-1 or PD-L1 inhibitors.

Current Clinical Trial

ONC-392 is currently being studied in a Phase 3 clinical trial called PRESERVE-003[1][2]. This is an important step in determining if the drug is effective and safe for widespread use. The trial is comparing ONC-392 to a chemotherapy drug called docetaxel, which is currently a standard treatment for this type of cancer.

Who is eligible for the trial?

The trial is open to adults (18 years or older) with metastatic NSCLC who meet certain criteria[1][2]. Some key eligibility factors include:

  • Confirmed diagnosis of metastatic NSCLC
  • Previous treatment with certain types of immunotherapy and chemotherapy
  • Cancer that has progressed despite previous treatments
  • Good overall health status (ECOG score of 0 or 1)
  • No active brain metastases or certain other medical conditions

How is ONC-392 administered?

ONC-392 is given as an intravenous infusion, which means it’s delivered directly into the bloodstream through a vein[1][2]. The dosing schedule being tested includes:

  • Two initial “loading” doses of 10 mg/kg, given three weeks apart
  • Followed by regular doses of 6 mg/kg every three weeks

Potential Benefits of ONC-392

The main goals of the ONC-392 treatment being studied are[1][2]:

  • To improve overall survival (helping patients live longer)
  • To increase the number of patients whose tumors shrink or disappear (objective response rate)
  • To extend the time before the cancer starts growing again (progression-free survival)

Possible Side Effects

As with any medication, ONC-392 may cause side effects. The clinical trial is carefully monitoring for any adverse events, including[1][2]:

  • Treatment-emergent adverse events (TEAEs)
  • Treatment-related adverse events (TRAEs)
  • Immune-related adverse events (irAEs)
  • Side effects that may lead to stopping treatment

It’s important to note that the full range of potential side effects is still being studied as part of the clinical trial process.

Aspect Details
Drug Name ONC-392 (Humanised IgG1 Monoclonal Antibody Against CD152)
Condition Metastatic Non-Small Cell Lung Cancer (NSCLC)
Trial Phase Phase 3
Study Design Randomized, open-label, active-controlled
Comparison ONC-392 vs. Docetaxel
Primary Endpoint Overall Survival (OS)
Secondary Endpoints Objective Response Rate (ORR), Progression-Free Survival (PFS), Safety and Tolerability
Dosing ONC-392: 6 mg/kg every 3 weeks with two initial loading doses of 10 mg/kg
Key Eligibility Adults with metastatic NSCLC, progressed on PD-1/PD-L1 inhibitors, ECOG score 0-1
Maximum Treatment Period 52 weeks

FAQ

  • What is ONC-392 and how does it work? ONC-392 is a new drug containing Humanised IgG1 Monoclonal Antibody Against CD152. It works by targeting a specific protein in the immune system, potentially helping to boost the body's natural defenses against cancer cells.
  • Who is eligible for these clinical trials? The trials are open to adults (18 years or older) with confirmed metastatic non-small cell lung cancer who have experienced disease progression after treatment with PD-1/PD-L1 inhibitors. Participants must have at least one measurable tumor and meet specific health criteria.
  • How is ONC-392 administered in the trials? ONC-392 is given as an intravenous infusion every three weeks. Some patients receive a higher initial dose (loading dose) followed by a lower maintenance dose.
  • What are the main goals of these clinical trials? The primary goal is to assess whether ONC-392 improves overall survival compared to docetaxel. Secondary goals include evaluating tumor response rates, progression-free survival, and the safety and tolerability of ONC-392.
  • How long do the clinical trials last? The maximum treatment period mentioned in the trials is 52 weeks (about one year). However, the actual duration may vary depending on how patients respond to the treatment and other factors.

Ongoing Clinical Trials on Humanised Igg1 Monoclonal Antibody Against Cd152

  • Study Comparing ONC-392 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After PD-1/PD-L1 Inhibitor Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Italy The Netherlands Spain

  • Study Comparing ONC-392 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After PD-1/PD-L1 Treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Italy Spain

Glossary

  • Metastatic Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that has spread from the lungs to other parts of the body, such as lymph nodes or distant organs.
  • PD-1/PD-L1 inhibitors: A type of immunotherapy drug that helps the immune system recognize and attack cancer cells by blocking certain proteins.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • ECOG score: A scale used to assess a patient's level of functioning in terms of their ability to care for themselves and engage in daily activities.
  • Blinded Independent Central Review (BICR): A process where medical experts who don't know the patient's treatment review their test results to determine how well the treatment is working.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the treatment, whether or not it is related to the medical treatment.

References

  1. http://clinicaltrials.eu/trial/study-comparing-onc-392-and-docetaxel-for-patients-with-metastatic-non-small-cell-lung-cancer-after-pd-1-pd-l1-treatment/
  2. http://clinicaltrials.eu/trial/study-comparing-onc-392-and-docetaxel-for-patients-with-metastatic-non-small-cell-lung-cancer-after-pd-1-pd-l1-inhibitor-treatment/