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Evaluation of Safety, Pharmacokinetics, and Efficacy of RO7782493 and Panitumumab in Advanced Solid Tumors with KRAS G12D Mutation

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced or metastatic solid tumors that have a specific genetic change known as the KRAS G12D mutation. The study will evaluate a new treatment called GDC-7035, which will be tested both on its own and in combination with other cancer treatments. The goal is to understand how safe this treatment is for patients and how it behaves in the body.

Participants in the study will receive the treatment in the form of a film-coated tablet or through an IV infusion, which is a method of delivering medication directly into the bloodstream. The study will also involve another medication called Vectibix, which is given as a solution for infusion. The trial aims to observe any side effects and how the body responds to the treatment over time.

The study will take place over several years, with researchers closely monitoring the health and progress of participants. They will look at various factors, such as changes in vital signs and laboratory test results, to determine the treatment's effectiveness and safety. The ultimate purpose is to gather information that could lead to better treatment options for patients with these types of tumors.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, you will undergo a series of baseline tests. these include measurements of vital signs such as blood pressure and heart rate, blood laboratory tests, an electrocardiogram (ecg) to check heart rhythm, and imaging scans to document the current size of the tumors.

    The purpose of these assessments is to create a reference point that will be used to compare future changes during the study.

  2. Step 2

    Start oral study drug (ro7782493)

    You will begin taking ro7782493, an oral film‑coated tablet. the tablet is taken by mouth according to the dosing schedule defined by the study protocol. the exact dose and how often you take the tablet (for example, once daily) will be explained by the study team and may be adjusted during the trial.

    The medication is taken on an empty stomach unless the protocol specifies otherwise.

  3. Step 3

    Dose‑escalation period

    During the early part of the study, the dose of ro7782493 may be gradually increased to find the highest dose that can be tolerated safely. each increase will be made only after a review of safety data such as side effects and laboratory results.

    You will continue to take the oral tablet at the new dose level for a defined period, typically several weeks, before the next evaluation.

  4. Step 4

    Addition of iv infusion (panitumumab)

    Once a safe dose of ro7782493 has been identified, you may receive panitumumab in combination with the oral tablet. panitumumab is given by iv infusion, which means the medication is delivered slowly into a vein through a small needle or catheter.

    The infusion is administered in a clinic setting, usually over a period of 30 to 60 minutes, and the schedule (for example, once every two weeks) will be set by the study protocol.

  5. Step 5

    Regular safety monitoring visits

    Throughout the treatment period you will attend regular clinic visits. at each visit you will have vital signs checked, blood drawn for laboratory tests, and an ecg performed to monitor heart function.

    Any side effects you experience will be recorded and graded according to a standard scale. the study team will use this information to decide whether the current dose can be continued, reduced, or stopped.

  6. Step 6

    Tumor response evaluations

    Periodically (for example, every 6 to 8 weeks) imaging scans such as CT or MRI will be performed to assess changes in tumor size. these results help determine the effectiveness of the treatment.

    The scans are compared with the baseline images to calculate measures such as objective response rate and duration of response.

  7. Step 7

    Treatment discontinuation and follow‑up

    Treatment may be stopped if the disease progresses, if unacceptable side effects occur, or after a predefined maximum treatment duration.

    After stopping the study drugs, you will continue to be followed for a period of time to monitor long‑term safety and disease status. follow‑up visits will include the same safety assessments and imaging as during treatment.

Who can join the trial?

4 criteria

  • Have a solid tumor that is advanced (large or difficult to treat) or has spread to other parts of the body (metastatic) and have a tissue test (called histology) that shows the specific genetic change known as KRAS G12D mutation.
  • Be at least 18 years old.
  • Agree to follow the study’s birth‑control rules if you could become pregnant (childbearing potential) or, for men, if you are able to produce sperm.
  • Both men and women are allowed to take part in the study.

Who cannot join the trial?

3 criteria

  • Having a condition that makes it hard for your body to absorb nutrients or medicines from the gut (this is called malabsorption or any problem that blocks enteral absorption)
  • Having cancer that has spread to the brain and is currently active (known as brain metastases)
  • Having serious heart problems (cardiovascular dysfunction) or serious liver problems (liver disease) that affect your overall health
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Investigated drugs

  • RO7782493

    is an experimental oral tablet that is taken by mouth. In this study the tablet is being tested on its own and together with other cancer medicines to see if it is safe for people with advanced solid tumors that have a specific KRAS G12D mutation. Researchers will also look at how the drug moves through the body and how the body reacts to it.

  • panitumumab

    is a medication given through an IV infusion (a drip into a vein). It is a type of targeted therapy that works by attaching to a protein called EGFR on cancer cells, which can help slow the growth of the tumor. In this trial panitumumab is combined with the experimental drug to evaluate whether the combination is safe for patients with advanced solid tumors that carry the KRAS G12D mutation.

What is already known about the treatment

  • RO7782493

    This medication is taken by mouth as a film‑coated tablet. It is an experimental drug that is still being studied and has not yet received market approval. It is being tested mainly for cancers that have a KRAS G12D mutation, a change that helps tumors grow. The drug works by attaching to the mutant KRAS protein and stopping the signals that tell cancer cells to multiply, placing it in the class of KRAS‑targeted small‑molecule inhibitors.

  • PANITUMUMAB

    This medication is given through an IV infusion directly into a vein. It is an approved cancer medicine that has been used for several years in treating certain colorectal cancers. It is used when tumors show a protein called EGFR, which helps the cancer grow. Panitumumab works by binding to EGFR on the cell surface, blocking the signals that promote tumor growth, and it belongs to the class of anti‑EGFR monoclonal antibodies.

Investigated diseases

Advanced/metastatic solid tumors with KRAS G12D mutation - These are cancers that form a solid mass in organs such as the lung, colon, pancreas, or other tissues. The tumors contain a specific KRAS gene change called the G12D mutation, which drives uncontrolled cell growth. In the advanced stage, the cancer has spread beyond its original site to nearby tissues or distant organs. As the disease progresses, the amount of tumor increases and may involve multiple locations. The mutation remains present throughout the disease course, influencing how the cancer behaves.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515144-23-00Protocol codeGO45416Estimated enrolment701 patientsSponsorGenentech Inc.

sourced from the EU Clinical Trials Register and site verification

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