In short
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.
Key points
- Clinical trials of Amg 193 are studying adults with advanced MTAP-null solid tumors and MTAP-deleted non-small cell lung cancer. The program includes early-phase studies and a phase 2 study. Some trials test Amg 193 alone, while others test it with IDE397 or docetaxel. The main goals are to check safety, tolerability, dose, and anti-cancer activity. The studies also measure tumor response and use scan-based rules such as RECIST 1.1. These trials focus on people with locally advanced or metastatic disease.
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.
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.
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.
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.
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.
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.
The studies also track vital signs, electrocardiograms (heart rhythm tests), and clinical laboratory tests to watch for changes during treatment.
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.
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.
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.
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.
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.
Some parts of the program test Amg 193 alone, while other parts test it with IDE397 or docetaxel.
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.
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.
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.
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.
NCT06593522 is an authorised phase 2 study with 211 participants, focused on MTAP-deleted advanced non-small cell lung cancer.
This study evaluates two dose levels of Amg 193, looks at response by blinded independent central review, and also records safety and pharmacokinetic results.
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.
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.
Serious adverse events are important medical problems that happen during a study and need close attention.
Interventional means the study gives a treatment and then watches what happens, instead of only observing people without treatment.