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Amg 193

Clinical trials are studying Amg 193 in people with advanced MTAP-null solid tumors and MTAP-deleted non-small cell lung cancer. These studies are looking at safety, tolerability, and whether the treatment helps shrink cancer. They include early-phase and phase 2 research in adults with locally advanced or metastatic disease.

Table of contents

Trial overview

These studies are testing Amg 193 in people with advanced cancers that have MTAP loss, including MTAP-null solid tumors and MTAP-deleted non-small cell lung cancer.[1][2][3]

The trial program includes early research and a later phase 2 study, so the focus moves from safety and dose finding to checking whether the treatment helps the cancer respond.[1][2][3]

Who can participate

The main target population is adults with locally advanced or metastatic disease, which means the cancer has grown beyond its original area or spread to other parts of the body.[1][2]

One study includes people with advanced MTAP-null solid tumors in Part 1 and people with advanced MTAP-null non-small-cell lung cancer in Part 2.[1]

Another study includes adults with metastatic or locally advanced MTAP-null solid tumors, and a phase 2 study focuses on MTAP-deleted advanced non-small cell lung cancer.[2][3]

What the trials measure

The main early safety measures include dose-limiting toxicities, which are side effects that can stop the dose from being increased, and other treatment-related side effects.[1][2]

The studies also track vital signs, electrocardiograms (heart rhythm tests), and clinical laboratory tests to watch for changes during treatment.[1][2]

For cancer activity, the trials measure objective response, which means whether the tumor has a complete response or partial response on scans and investigator review.[2][3]

The phase 2 study also measures pharmacokinetic results, such as maximum concentration, time to maximum concentration, and area under the curve, which describe how much drug is in the body over time.[3]

Trial phases and designs

Phase 1 studies are mainly used to find a safe dose and learn more about side effects, and the completed study NCT05975073 fits this pattern.[1]

The authorised study NCT05094336 is a Phase 1/1b/2 trial, which means it moves from early safety work into later testing of how well the treatment works.[2]

The authorised phase 2 study NCT06593522 is designed to look more closely at safety and efficacy in MTAP-deleted advanced non-small cell lung cancer.[3]

Some parts of the program test Amg 193 alone, while other parts test it with IDE397 or docetaxel.[1][2]

Key trials in this article

NCT05975073 is a completed phase 1 study in 184 participants, testing Amg 193 with IDE397 in advanced MTAP-null solid tumors and advanced MTAP-null non-small-cell lung cancer.[1]

In Part 1, the study aimed to find the maximum tolerated dose, meaning the highest dose that can be given safely, and in Part 2 it looked at whether the cancer responded to treatment using RECIST 1.1.[1]

NCT05094336 is an authorised phase 1/1b/2 study with 654 planned participants, testing Amg 193 alone and with docetaxel in advanced MTAP-null solid tumors.[2]

Its early parts focused on safety, tolerability, and finding the maximum tolerated dose or recommended phase 2 dose, while Part 3 looked at objective response based on investigator tumor assessments.[2]

NCT06593522 is an authorised phase 2 study with 211 participants, focused on MTAP-deleted advanced non-small cell lung cancer.[3]

This study evaluates two dose levels of Amg 193, looks at response by blinded independent central review, and also records safety and pharmacokinetic results.[3]

What the main terms mean for patients

RECIST 1.1 is a standard set of rules used on scans to judge if cancer is shrinking, staying the same, or growing.[1][3]

Blinded independent central review means that scan results are checked by a separate review team that does not know which treatment the person received, which helps make the results more fair.[3]

Serious adverse events are important medical problems that happen during a study and need close attention.[2][3]

Interventional means the study gives a treatment and then watches what happens, instead of only observing people without treatment.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT05094336 Phase 1/1b/2 Advanced MTAP-null solid tumors Authorised 654
NCT05975073 Phase 1 Advanced MTAP-null solid tumors; advanced MTAP-null non-small-cell lung cancer Completed 184
NCT06593522 Phase 2 MTAP-deleted advanced non-small-cell lung cancer Authorised 211

FAQ

  • What are the Amg 193 clinical trials studying? These trials are studying whether Amg 193 can help treat advanced MTAP-null solid tumors and MTAP-deleted non-small cell lung cancer. They also measure safety, tolerability, and how the cancer responds to treatment.
  • Who can join these trials? The studies are for adults with locally advanced or metastatic disease. The main target groups are people with MTAP-null solid tumors and people with MTAP-deleted non-small cell lung cancer.
  • What phases are the Amg 193 trials? The trial program includes Phase 1, Phase 1/2, Phase 1/1b/2, and Phase 2 studies. Early-phase trials focus more on safety and dose finding, while later phases look more closely at effectiveness.
  • What do the trials measure? The studies measure dose-limiting toxicities, other treatment-related side effects, vital signs, ECGs, and lab tests. They also measure tumor response, including complete or partial response, using RECIST 1.1.
  • Are the trials testing Amg 193 alone or with other drugs? Both approaches are being studied. Some trials test Amg 193 alone, while others test it in combination with IDE397 or docetaxel.

Ongoing Clinical Trials on Amg 193

  • Study of AMG 193 tablets for patients with advanced non-small cell lung cancer (NSCLC) who have previously received treatment and have MTAP gene deletion

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Hungary +6

  • Study of AMG 193 alone and combined with docetaxel for treatment of advanced MTAP-null solid tumors in adult patients

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany

  • Study of AMG 193 and IDE397 for Adults with Advanced MTAP-null Solid Tumors and Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Spain

Glossary

  • Advanced cancer: Cancer that has grown far enough to be harder to treat, often because it is locally advanced or has spread to other parts of the body.
  • Locally advanced: Cancer that has grown outside its original area but has not clearly spread to distant parts of the body.
  • Metastatic: Cancer that has spread from where it started to other organs or tissues.
  • MTAP-null: A tumor that does not have a working MTAP gene. This feature is being used to select patients for these studies.
  • MTAP-deleted: A tumor missing the MTAP gene. This is another way the trials identify eligible patients.
  • Phase 1: An early study phase that mainly checks safety, side effects, and dose.
  • Phase 2: A later study phase that looks more closely at whether the treatment works.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of a treatment can be given.
  • Adverse events: Medical problems or side effects that happen during a study, whether or not they are caused by the treatment.
  • RECIST 1.1: A set of rules used to measure whether a tumor is shrinking, staying the same, or growing on scans.
  • Objective response: A measured sign that the cancer has improved, such as a complete response or partial response.
  • Pharmacokinetic parameters: Measures of how the body handles a drug, such as the highest level in the blood and how long it stays there.

References