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Phase 1/2 Study of pumitamig Alone or Combined with ipilimumab or cabozantinib in Patients with Advanced Renal Cell Carcinoma

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What is this trial about?

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

The study involves people with Advanced Renal Cell Carcinoma, a type of kidney cancer that has spread beyond the kidney. It is testing a new medication called pumitamig, which may be given alone or together with either ipilimumab, an intravenous immune‑system drug, or cabozantinib, an oral pill that targets cancer‑growth pathways.

The purpose of the trial is to determine whether the new medication is safe and whether it can shrink tumors. In the early part of the trial (Phase 1), researchers look for side effects and try to find the best dose when the drugs are combined. In the later part (Phase 2), the focus shifts to how often the cancer becomes smaller or disappears, which is called an objective response.

Participants receive treatment in repeated cycles, with regular visits for infusions or for taking the oral pill, and doctors perform scans to watch the size of the tumors. Throughout the study, safety is checked by recording any side effects, and the time the cancer does not get worse (progression‑free survival) and the length of any tumor shrinkage (duration of response) are also recorded. The trial continues for several months with ongoing follow‑up visits.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After joining the study, a set of initial examinations is performed. these include a review of medical history, physical examination, laboratory tests, and imaging scans to document the current status of the kidney cancer.

  2. Step 2

    Start of phase 1 treatment

    The first treatment phase begins with the administration of pumitamig by intravenous infusion. depending on the assigned study group, pumitamig may be given alone, together with ipilimumab (also an intravenous infusion), or together with cabozantinib (an oral medication).

    The exact dose and frequency of each medication are defined by the study protocol and are administered according to the schedule determined by the investigators.

  3. Step 3

    Administration of ipilimumab (if assigned)

    When ipilimumab is part of the assigned regimen, it is delivered by intravenous infusion at the times specified in the protocol. the infusion is performed in a clinical setting under medical supervision.

  4. Step 4

    Administration of cabozantinib (if assigned)

    When cabozantinib is part of the assigned regimen, it is taken by mouth as directed by the study schedule. the medication is swallowed with water and taken at the frequency outlined in the protocol.

  5. Step 5

    Regular safety monitoring

    Throughout the treatment period, routine visits are scheduled to check for side effects. during each visit, laboratory tests are repeated, vital signs are recorded, and any new symptoms are reported to the study team.

  6. Step 6

    Tumor response assessments

    Periodic imaging scans are performed to evaluate whether the kidney tumor has shrunk, remained stable, or grown. the results are used to determine the effectiveness of the treatment.

  7. Step 7

    Continuation or discontinuation of treatment

    Treatment continues as long as the disease does not worsen, side effects are manageable, and the study duration has not been reached. the investigator may stop a medication if serious side effects occur or if the disease progresses.

  8. Step 8

    End‑of‑treatment visit

    When treatment is stopped, a final assessment is performed. this includes a complete physical exam, laboratory tests, and imaging to document the status of the cancer at the end of therapy.

  9. Step 9

    Follow‑up period

    After the end of treatment, follow‑up visits are scheduled to monitor long‑term safety and survival. during these visits, the study team records any late side effects and checks whether the cancer remains controlled.

Who can join the trial?

6 criteria

  • Adult (18 years or older) with kidney cancer that has grown large or spread and cannot be removed by surgery. (Kidney cancer that is advanced or metastatic means it cannot be cured by cutting it out.)
  • In the first part of the study (Phase 1) most kinds of kidney cancer are allowed; in the second part (Phase 2) only the clear cell type of kidney cancer is accepted. (Clear cell type is the most common form of kidney cancer.)
  • You must have adequate organ function. (This means your heart, liver, kidneys, and blood‑forming systems work well enough to handle the study medicines.)
  • No previous use of certain cancer medicines is allowed in Phase 2, except for a few special cases. (This ensures the new drug is tested without interference from other similar treatments.)
  • You need to have at least one tumor that can be seen on imaging scans such as CT or MRI. (A scan is a picture of the inside of your body that doctors use to locate tumors.)
  • Both men and women are eligible to join the study.

Who cannot join the trial?

5 criteria

  • If the cancer has spread to the brain and has not been treated (this is called brain metastasis).
  • If you need strong medicines that lower the body’s ability to fight infections, known as immune‑suppressing drugs.
  • If you have serious problems with your lungs, heart, blood clotting, or have had recent major surgery.
  • If you have a large amount of fluid collecting around the heart or lungs (called pericardial or pleural effusion).
  • If you have recent serious stomach or intestinal issues, such as severe ulcers, bleeding, or blockage.
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Investigated drugs

  • Ipilimumab

    is an intravenous medication that helps the immune system recognize and attack cancer cells. In this study it is given together with the experimental drug to see if the combination can improve the treatment of advanced kidney cancer.

  • Cabozantinib

    is an oral tablet that blocks signals that help cancer cells grow and spread. In the trial it is taken with the experimental drug to test whether the two together work better than each one alone for kidney cancer.

  • Pumitamig

    (also called BNT327) is the new investigational drug being tested. It is given by intravenous infusion and is studied both by itself and in combination with the other two medicines to determine its safety, the best dose, and how well it can shrink kidney cancer tumors.

What is already known about the treatment

  • Ipilimumab

    Ipilimumab is given as an intravenous infusion using a concentrate that is mixed with fluid before it is slowly injected into a vein. It is an approved medicine that has been studied extensively for cancers such as melanoma and kidney cancer. The drug works by blocking a protein called CTLA‑4, which lifts the brakes on the immune system and helps T‑cells attack tumor cells. It belongs to the class of immune checkpoint inhibitors, which are a type of monoclonal antibody therapy.

  • Cabozantinib

    Cabozantinib is taken as an oral tablet that the patient swallows with water. It is already approved and widely reported in the medical literature for treating advanced kidney cancer and other solid tumors. The medication blocks several enzymes called tyrosine kinases (including VEGFR, MET, and AXL), which slows the growth of blood vessels that feed the tumor and reduces tumor growth. It is classified as a multi‑targeted tyrosine kinase inhibitor.

  • Pumitamig

    Pumitamig is administered by intravenous infusion using a concentrate that is diluted and delivered directly into a vein. It is an investigational drug that is currently being tested in early‑phase clinical trials and has not yet received market approval. The agent is designed to stimulate specific pathways that promote healthy blood vessel formation and may help the immune system recognize cancer cells. It is classified as an experimental peptide therapeutic aimed at modulating angiogenesis.

Investigated diseases

Advanced renal cell carcinoma - Renal cell carcinoma is a cancer that starts in the cells of the kidney. In the advanced stage, the tumor has grown beyond the kidney and may spread to nearby tissues or distant organs. The disease typically progresses with increasing tumor size and spread, leading to worsening kidney function and involvement of other body parts.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-527163-15-00Protocol codeCA2660008Estimated enrolment254 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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