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Study of RMC-6291 with ivonescimab drug combination in patients with advanced RAS‑mutated solid tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on patients with Solid Tumors that have a change called RAS‑mutated. The investigational medicines being tested include an intravenous antibody named ivonescimab and a group of oral drugs referred to as RAS(ON) inhibitors. Specific pills that may be used are RMC‑6291, DARAXONRASIB (RMC‑6236) and RMC‑9805. These agents can also be given together with standard chemotherapy drugs such as cisplatin.

The purpose of the study is to evaluate safety and find the best dose of the new medicines when used alone or in combination. Participants receive an IV infusion, which means the medicine is delivered directly into a vein, and they swallow tablets on a regular schedule. Treatment cycles are repeated every few weeks, and patients return to the clinic for regular check‑ups, blood tests, and simple examinations to watch for any side effects.

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, initial examinations are performed to record medical history, current health status, and laboratory test results.

    Imaging studies are done to document the size and location of solid tumors before any treatment is given.

  2. Step 2

    First administration of ivonescimab

    The patient receives ivonescimab by intravenous infusion. the specific dose, frequency, and duration are defined in the study protocol but are not detailed in the provided information.

    The infusion is given in a clinical setting where vital signs are monitored during and after the procedure.

  3. Step 3

    Administration of additional anti‑cancer agents

    Depending on the study arm, the patient may also receive one or more of the following agents:

    erbitux 5 mg/ml solution for infusion (contains cetuximab) given by infusion;

    cisplatin hikma 1 mg/ml solution for infusion;

    carboplatin kabi 10 mg/ml solution for infusion;

    pemetrexed 25 mg/ml concentrate for infusion.

    Each medication is administered by infusion according to the schedule defined by the trial, which is not specified in the source data.

  4. Step 4

    Oral tablet therapy

    The patient takes oral tablets that are part of the study regimen:

    rmc‑6291 tablet;

    daraxonrasib (rmc‑6236) tablet;

    rmc‑9805 tablet.

    The exact dose, how many times per day, and the total length of treatment are determined by the protocol but are not provided in the source information.

  5. Step 5

    Regular safety monitoring

    Throughout the trial, the patient undergoes repeated laboratory tests, including blood counts and chemistry panels, to detect any adverse effects.

    Vital signs such as blood pressure, heart rate, and temperature are checked at each visit.

    Any side effects, serious adverse events, or dose‑limiting toxicities are recorded according to the study’s safety objectives.

  6. Step 6

    Tumor response evaluation

    Periodic imaging (for example, CT or MRI scans) is performed to assess changes in tumor size.

    The results are compared with baseline images to determine response according to RECIST v1.1 criteria, which classify outcomes such as partial response, stable disease, or progression.

  7. Step 7

    Continuation or discontinuation of treatment

    Treatment cycles are repeated as long as the patient meets eligibility criteria and does not experience unacceptable toxicity.

    The study may end for the patient when the predefined treatment period is completed, when disease progression occurs, or when the patient chooses to stop therapy.

Who can join the trial?

5 criteria

  • You must be at least 18 years old.
  • You must have a cancer that carries a RAS mutation, and the cancer must be advanced (it has spread or cannot be removed by surgery).
  • You must have at least one tumor that doctors can see and measure on imaging scans (a measurable tumor).
  • If a part of the study requires a particular type of RAS mutation, you must have that specific mutation.
  • You must have adequate organ function, meaning your heart, liver, kidneys and other vital organs work well enough for the treatment.

Who cannot join the trial?

4 criteria

  • Cannot have taken medicines that directly target RAS, or certain immune or anti-VEGF therapies (drugs that block a signal that helps tumors grow new blood vessels).
  • Cannot have any medical condition such as a bleeding problem or an active infection that could interfere with the study drug.
  • Cannot be pregnant or breastfeeding.
  • May be excluded if you have already received cancer treatment when the specific part of the study does not allow prior treatment.
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Investigated drugs

  • Ivonescimab

    is an experimental drug given by IV infusion. It is a type of antibody that is being studied to see if it can help the immune system recognize and attack cancer cells. In this trial it is combined with other medicines to test its safety and how well it works.

  • Cetuximab

    (sold as Erbitux) is an approved medicine that blocks a protein called EGFR on cancer cells. By stopping EGFR, it can slow the growth of some tumors. In the study it is used together with ivonescimab to see if the two drugs work better together.

  • Cisplatin

    is a chemotherapy drug given through an IV solution. It works by damaging the DNA of cancer cells, which can stop them from growing. In this trial it may be added to the combination of ivonescimab and other agents to see how the mix is tolerated.

  • Carboplatin

    is another chemotherapy medicine delivered by IV infusion. Like cisplatin, it interferes with the DNA of cancer cells to stop their growth. It is being tested in combination with ivonescimab and other study drugs.

  • Pemetrexed

    is a chemotherapy drug that is given as an IV infusion. It stops cancer cells from making the building blocks they need to multiply. In the trial it may be used alongside ivonescimab and other treatments.

  • RMC-6291

    is an oral, experimental medication that targets the active form of the RAS protein inside cancer cells. By blocking this protein, the drug aims to stop tumor growth. The study is looking at how safe it is and what dose works best when combined with ivonescimab.

What is already known about the treatment

  • Ivonescimab

    This drug is given as an intravenous infusion using a sterile injection. It is still investigational and is being studied in early clinical trials. The medication is being tested for solid tumors that have RAS mutations. It works by attaching to a specific protein that keeps the RAS pathway active, thereby blocking the signal that tells cancer cells to grow; it belongs to the class of monoclonal antibody targeted therapies.

  • Cetuximab

    Cetuximab is supplied as a solution for infusion and is administered through an IV line. It is an approved cancer medicine used for colorectal and head‑and‑neck cancers. The drug binds to the epidermal growth factor receptor (EGFR) on the surface of cells, stopping the signal that promotes tumor growth. It is classified as an EGFR‑targeting monoclonal antibody.

  • Cisplatin

    Cisplatin comes as a solution for infusion that is delivered by intravenous injection. It is a well‑established chemotherapy drug used for many solid tumors such as testicular, ovarian, and lung cancers. The compound creates cross‑links in DNA, which prevents cancer cells from dividing and leads to their death. It belongs to the class of platinum‑based chemotherapy agents.

  • Carboplatin

    Carboplatin is also provided as a solution for infusion and is given by IV. It is an approved chemotherapy used for ovarian, lung, and other solid cancers. Like cisplatin, it forms DNA cross‑links that stop cancer cells from multiplying, but it generally causes fewer side effects. It is classified as a platinum‑based chemotherapy drug.

  • Pemetrexed

    Pemetrexed is supplied as a concentrate for solution for infusion and is administered intravenously. It is an approved treatment for malignant pleural mesothelioma and non‑small cell lung cancer. The agent blocks enzymes needed to make DNA building blocks, which halts tumor cell growth. It is an antifolate chemotherapy agent.

  • RMC‑6291

    RMC‑6291 is taken as an oral tablet. It is an experimental drug currently in early‑stage clinical testing. The medication is being evaluated for solid tumors that carry RAS mutations. It works by inhibiting the active form of the RAS protein, stopping the growth signal; it is classified as an oral RAS(ON) inhibitor, a type of targeted therapy.

Investigated diseases

Solid tumor - A solid tumor is an abnormal mass of tissue that forms when cells grow uncontrollably. These growths develop in organs or tissues such as the breast, lung, colon, or bone and remain localized at first. Over time, they can enlarge and may invade nearby structures, spreading into surrounding tissues. As they grow, they can acquire additional changes that allow them to spread to distant parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524623-50-00Protocol codeRMC-APEX-103Estimated enrolment370 patientsSponsorRevolution Medicines Inc.

sourced from the EU Clinical Trials Register and site verification

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