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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

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.

Table of Contents

Trial overview

The available trial is an interventional study, which means researchers give a treatment and then measure what happens.[1] 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.[1]

The study brief says the goal is to find the recommended phase 2 dose, check safety and tolerability, and look for antitumor activity.[1] The drug is being studied both as monotherapy, meaning by itself, and in combination with other anticancer therapies.[1]

Who can participate

The target population is patients with KRAS G12C-mutant advanced solid tumors.[1] 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.[1]

Study design and phase

The study is in Phase 1/2, which is an early stage of clinical research.[1] Early-phase trials often focus on safety, dose finding, and first signs that a treatment may help.[1]

The planned enrollment is 680 participants, which is the number of people the study aims to include.[1] The status is Authorised.[1]

What the trials measure

The main safety measure is dose limiting toxicity (DLT) rate and DLT-equivalent toxicities.[1] 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.[1] 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.[1]

Trial details

The brief summary says the study is designed to identify the optimal dose and the recommended phase 2 dose.[1] It also aims to understand whether the treatment has enough early activity to support later research.[1]

Only one trial record is provided in the source data, so this article focuses on that study.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04956640 Phase 1/2 KRAS G12C-Mutant Advanced Solid Tumors Authorised 680

FAQ

  • What are these trials studying? They 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 as a cancer treatment given alone and with other anticancer therapies. The main goals are to find the recommended dose and to see how well it works in KRAS G12C-mutant advanced solid tumors.
  • Who can take part in the study? The trial is for patients with KRAS G12C-mutant advanced solid tumors. This means the cancer has a specific genetic change called KRAS G12C and is in an advanced stage.
  • What phase is the trial? The study is in Phase 1/2. Early phases usually focus on safety, dose finding, and early signs of benefit.
  • What results are being measured? The study measures dose limiting toxicity, which means side effects that stop dose increase, and DLT-equivalent toxicities. It also tracks treatment-related side effects, serious side effects, deaths, lab test changes, and antitumor activity.
  • How many people are planned for the trial? The planned enrollment is 680 people. That is the number of participants the study aims to include.

Ongoing Clinical Trials on 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

  • Study of LY3537982 for Patients with Advanced Solid Tumors with KRAS G12C Mutation

    Recruiting

    1 1 1
    Investigated drugs:
    France

Glossary

  • Advanced solid tumors: Solid cancers that have spread or are no longer controlled by standard treatment.
  • KRAS G12C: A specific genetic mutation found in some cancers. Trials may target patients whose tumors carry this change.
  • Interventional study: A study where participants receive a treatment or test so researchers can measure its effects.
  • Phase 1/2: An early stage of research that checks safety, finds the best dose, and looks for early signs that the treatment may work.
  • Dose limiting toxicity: A side effect severe enough to prevent increasing the dose further.
  • DLT-equivalent toxicities: Side effects considered similar in importance to dose limiting toxicity.
  • Treatment-emergent adverse events: Side effects that start or get worse after treatment begins.
  • Serious adverse events: Severe side effects that may be life-threatening, require hospital care, or cause major harm.
  • Clinical laboratory abnormalities: Unusual results on blood or other lab tests that may show a safety problem.
  • Antitumor activity: Signs that a treatment may help shrink cancer, slow it down, or control it.
  • Recommended phase 2 dose: The dose chosen for later studies after early testing shows it may be the best balance of safety and activity.

References