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Study on JAB-21822 for Adults with Advanced Solid Tumors with KRAS G12C Mutation

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What is this study about?

This clinical trial is focused on studying a type of cancer known as advanced solid tumors that have a specific genetic change called the KRAS G12C mutation. The treatment being tested is a new medication called JAB-21822, which is taken as a tablet. The study aims to understand how safe and tolerable this medication is for patients, as well as its potential effectiveness in treating these tumors.

The study is divided into two phases. In the first phase, the focus is on determining the best dose of JAB-21822 that can be given safely to patients. This phase will also look at how the body processes the medication. In the second phase, the study will further explore how well JAB-21822 works in shrinking tumors, both on its own and in combination with another drug called cetuximab for a specific type of cancer known as metastatic colorectal cancer with the same mutation.

Throughout the study, participants will receive regular check-ups to monitor their health and any side effects they may experience. The study will continue until the end of 2025, with the goal of gathering enough information to understand the potential benefits and risks of using JAB-21822 as a treatment option for these types of cancer.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the necessary criteria, such as having a measurable lesion and a confirmed KRAS G12C mutation in their tumor.

The participant must have previously received at least one standard therapy and be able to swallow tablets.

2 dose escalation phase (phase 1)

The participant will begin taking the medication JAB-21822, which is administered orally in the form of a tablet.

The purpose of this phase is to evaluate the safety and tolerability of the medication and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).

The participant will be monitored for any side effects and changes in clinical laboratory measurements, ECG findings, vital signs, and physical examination results.

3 dose expansion phase (phase 2)

In this phase, the participant will continue to take JAB-21822 at the RP2D determined in phase 1.

The focus will be on evaluating the preliminary antitumor activity of the medication, including the overall response rate (ORR) and duration of response (DOR).

Participants with non-small cell lung cancer (NSCLC) and other solid tumors will receive the monotherapy, while those with metastatic colorectal cancer (mCRC) will receive a combination therapy with cetuximab.

4 follow-up period

After completing the treatment cycles, the participant will enter a follow-up period to monitor long-term safety and any lasting effects of the treatment.

The participant’s health status, including any adverse events, will be recorded and analyzed.

Who Can Join the Study?

  • Participants must have at least one measurable lesion, which is a tumor that can be measured in size, as defined by a specific guideline called RECIST v1.1.
  • Participants must be able to provide a sample of their tumor that was previously collected and stored.
  • Participants must have solid tumors confirmed by tests called histology or cytology, and these tumors must have a specific change in the KRAS gene known as the G12C mutation.
  • Participants must have received at least one standard treatment before joining the study.
  • Participants must be able to swallow and keep down medication that is taken by mouth.
  • Participants must have certain laboratory test results that meet specific criteria, including:
    • An absolute neutrophil count, which is a type of white blood cell, of at least 1.5 x 109/L.
    • A platelet count, which helps with blood clotting, of at least 100 x 109/L.
    • Hemoglobin, a protein in red blood cells, of at least 9 g/dL.
    • Albumin, a protein in the blood, of at least 3.0 g/dL.
    • Total bilirubin, a substance made by the liver, of no more than 1.5 times the upper limit of normal (ULN), or 2.0 times ULN if the participant has Gilbert’s syndrome, a mild liver condition.
    • AST and ALT, which are liver enzymes, of no more than 1.5 times ULN, or 3 times ULN if there are liver metastases, which means cancer has spread to the liver.
    • PT and PTT, which are tests for blood clotting, of less than 1.5 times ULN, and INR, another clotting test, of less than 1.5 if not on blood thinners, or less than 3 if on blood thinners after adjusting the dose.
    • Normal kidney function with a creatinine clearance (CrCl) of at least 60 mL/min, which is a measure of how well the kidneys are working.
    • TSH, a thyroid hormone level, must be within the normal range at the start of the study. Additional thyroid tests can be done if needed.
  • Participants can be of any gender.
  • Participants must be adults, typically aged 18 years and older.

Who Cannot Join the Study?

  • Patients who do not have advanced solid tumors with a KRAS G12C mutation cannot participate. This means the study is only for those with a specific type of cancer mutation.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
04.05.2022

Trial locations

Investigated drugs:

JAB-21822 is an investigational medication being studied for its potential to treat advanced solid tumors that have a specific genetic mutation known as KRAS G12C. This medication is being tested to see how safe and tolerable it is for patients, as well as to understand how it behaves in the body. Researchers are also looking at its ability to reduce or eliminate tumors in patients who have not responded to other treatments.

Cetuximab is a medication that is already used to treat certain types of cancer. In this study, it is being combined with JAB-21822 to see if the combination is more effective in treating metastatic colorectal cancer (mCRC) that has the KRAS G12C mutation. Cetuximab works by targeting specific proteins on the surface of cancer cells, which can help slow down or stop their growth.

Investigated diseases:

Advanced Solid Tumors with KRAS G12C Mutation – This condition involves a group of cancers that originate in solid organs or tissues and have a specific genetic mutation known as KRAS G12C. These tumors can occur in various parts of the body, such as the lungs, colon, or pancreas. The KRAS G12C mutation leads to abnormal cell growth and division, contributing to cancer progression. Over time, these tumors may grow larger and potentially spread to other parts of the body. The presence of the KRAS G12C mutation can influence the behavior of the tumor and its response to certain treatments. Understanding the mutation is crucial for developing targeted therapies that can more effectively manage the disease.

Trial ID:
2024-515258-25-00
Protocol code:
JAB-21822-1001
NCT ID:
NCT05002270
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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