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 study about?

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.

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 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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Turku University Hospital	Turku	Finland
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Fmjhjrep nektuhyws Myvgv a Hoyovgt	Prague	Czechia
Hdfcbrjy Ucmvgrymds Clkfxvs Hinczhgk	Helsinki	Finland
Pzawodvqcf hnbbdvxkrgxwvkl	Tampere	Finland

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.10.2026
Finland	Not yet recruiting	01.10.2026

Trial locations

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.

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 ID:

2026-527163-15-00

Protocol code:

CA2660008

NCT ID:

NCT07293351

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?