In short
Clinical trials are investigating 2-AMINO-4-[(4AS)-8-CHLORO-10-FLUORO-2,3,4,4A,5,6-HEXAHYDRO-12-OXO-3-(1-OXO-2-PROPEN-1-YL)-1H,12H-PYRAZINO[2,1-D][1,5]BENZOXAZOCIN-9-YL]-7-FLUORO-BENZO[B]THIOPHENE-3-CARBONITRILE in people with KRAS G12C-mutant advanced solid tumors. The studies aim to find the best dose, check safety and tolerability, and measure antitumor activity. They include early-phase patients and test the drug alone and with other cancer treatments.
Key points
- Clinical trials are studying 2-AMINO-4-[(4AS)-8-CHLORO-10-FLUORO-2,3,4,4A,5,6-HEXAHYDRO-12-OXO-3-(1-OXO-2-PROPEN-1-YL)-1H,12H-PYRAZINO[2,1-D][1,5]BENZOXAZOCIN-9-YL]-7-FLUORO-BENZO[B]THIOPHENE-3-CARBONITRILE in people with KRAS G12C-mutant advanced solid tumors. The main trial is Phase 1/2 and is designed to find the recommended dose, check safety, and look for early antitumor activity. It includes use of the drug alone and with other anticancer therapies. The planned enrollment is 680 participants. The trial status is Authorised.
Trial overview
The available trial is an interventional study, which means researchers give a treatment and then measure what happens. It is studying 2-AMINO-4-[(4AS)-8-CHLORO-10-FLUORO-2,3,4,4A,5,6-HEXAHYDRO-12-OXO-3-(1-OXO-2-PROPEN-1-YL)-1H,12H-PYRAZINO[2,1-D][1,5]BENZOXAZOCIN-9-YL]-7-FLUORO-BENZO[B]THIOPHENE-3-CARBONITRILE in people with KRAS G12C-mutant advanced solid tumors.
The study brief says the goal is to find the recommended phase 2 dose, check safety and tolerability, and look for antitumor activity. The drug is being studied both as monotherapy, meaning by itself, and in combination with other anticancer therapies.
Who can participate
The target population is patients with KRAS G12C-mutant advanced solid tumors. This means the cancer must have the KRAS G12C genetic change and must be an advanced solid tumor.
The trial data do not list more detailed entry rules in the source provided.
Study design and phase
The study is in Phase 1/2, which is an early stage of clinical research. Early-phase trials often focus on safety, dose finding, and first signs that a treatment may help.
The planned enrollment is 680 participants, which is the number of people the study aims to include. The status is Authorised.
What the trials measure
The main safety measure is dose limiting toxicity (DLT) rate and DLT-equivalent toxicities. A DLT is a side effect that is serious enough to stop dose increase.
The study also measures treatment-emergent adverse events, serious adverse events, deaths, and clinical laboratory abnormalities. These measures help researchers see how safe the treatment is and whether it causes important lab changes.
Another key endpoint is antitumor activity of 2-AMINO-4-[(4AS)-8-CHLORO-10-FLUORO-2,3,4,4A,5,6-HEXAHYDRO-12-OXO-3-(1-OXO-2-PROPEN-1-YL)-1H,12H-PYRAZINO[2,1-D][1,5]BENZOXAZOCIN-9-YL]-7-FLUORO-BENO[b]THIOPHENE-3-CARBONITRILE.
Trial details
The brief summary says the study is designed to identify the optimal dose and the recommended phase 2 dose. It also aims to understand whether the treatment has enough early activity to support later research.
Only one trial record is provided in the source data, so this article focuses on that study.