New hope for advanced kidney cancer: experimental drug pumitamig enters human trials

NCT ID NCT07293351

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This study tests a new drug called pumitamig, alone or combined with ipilimumab or cabozantinib, in 254 people with advanced kidney cancer that cannot be removed by surgery. The goal is to see if the drug is safe and can shrink tumors. Participants must have a confirmed diagnosis of renal cell carcinoma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Pumitamig (also called BMS-986545, BNT327, PM8002), a drug given alone or with ipilimumab or cabozantinib
What this could lead to: If successful, this could provide a new treatment option for advanced kidney cancer that is not curable with current therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or may have significant side effects. Results may not apply to all kidney cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 474 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC). * Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC. * Participants may have favorable, intermediate or poor risk disease categories. * Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab). iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib. iv) For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed. \- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have any untreated known CNS metastases. * Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1). * Participants must not have a history of interstitial lung disease or pneumonitis. * Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures. * Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, left ventricular ejection fraction (LVEF) \<50% (for Part 2D and 2E) or congenital long QT syndrome. * Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine protein-creatinine ratio (UPCR) \> 1000 mg/g. * Participants must not have evidence of major coagulation disorders. * Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1. * Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months. * Participants must not have had a major surgery or trauma within 28 days prior to C1D1. * For Part 2D and 2E: Receiving ongoing concomitant treatment with sensitive substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 with narrow therapeutic indices within 5 half-lives of the concomitant treatment or up to 28 days, whichever is shorter, prior to randomization. * For Part 2D and 2E: Receiving ongoing concomitant treatment with moderate or strong CYP3A4 inducers, or moderate or strong CYP3A4 inhibitors within 5 half-lives of the concomitant treatment, or up to 28 days, whichever is shorter, prior to randomization. * For Part 2D and 2E: Has hypoxia defined by a pulse oximeter reading \< 92% at rest or requires intermittent or chronic supplemental oxygen. * For Part 2D and 2E: Exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%. * For Part 2D and 2E: Presence of significant pulmonary disease/condition (eg, chronic obstructive pulmonary disease, pleural effusion, etc) that, in the opinion of the Investigator, could put participant at increased risk from study intervention or impact interpretation of safety data. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced renal cell carcinoma (RCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

94 sites in 20 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Asociación de Beneficencia Hospital Sirio Libanés
RECRUITING

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1419, Argentina
Bradfordhill
RECRUITING

Santiago, Santiago Metropolitan, 8420383, Chile
Carolina Urologic Research Center, LLC
RECRUITING

Myrtle Beach, South Carolina, 29572, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
GenesisCare St Leonards
RECRUITING

St Leonards, New South Wales, 2065, Australia
HOCH Health Ostschweiz
RECRUITING

Sankt Gallen, 9007, Switzerland
Instituto Medico Especializado Alexander Fleming
RECRUITING

Buenos Aires, 1426, Argentina
Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
Kantonsspital Graubünden
RECRUITING

Chur, 7000, Switzerland
Kyushu University Hospital
RECRUITING

Fukuoka, 812-8582, Japan
Local Institution - 0003
NOT_YET_RECRUITING

Malvern, 3144, Australia
Local Institution - 0004
NOT_YET_RECRUITING

Heidelberg, Victoria, 3084, Australia
Local Institution - 0006
NOT_YET_RECRUITING

Québec, Quebec, G1R 2J6, Canada
Local Institution - 0007
NOT_YET_RECRUITING

Calgary, Alberta, T2N 5G2, Canada
Local Institution - 0009
NOT_YET_RECRUITING

Montreal, Quebec, H3T 1E2, Canada
Local Institution - 0011
NOT_YET_RECRUITING

Herston, Queensland, 4029, Australia
Local Institution - 0013
NOT_YET_RECRUITING

Madrid, 28041, Spain
Local Institution - 0014
NOT_YET_RECRUITING

Herne, 44649, Germany
Local Institution - 0017
NOT_YET_RECRUITING

Seoul, Seoul-teukbyeolsi, 05505, South Korea
Local Institution - 0022
NOT_YET_RECRUITING

Cambridge, CB2 2QQ, United Kingdom
Local Institution - 0025
NOT_YET_RECRUITING

Jena, Thuringia, 07747, Germany
Local Institution - 0026
NOT_YET_RECRUITING

Hamburg, 20251, Germany
Local Institution - 0027
NOT_YET_RECRUITING

München, 81675, Germany
Local Institution - 0028
NOT_YET_RECRUITING

Villejuif, 94805, France
Local Institution - 0029
NOT_YET_RECRUITING

Turku, 20521, Finland
Local Institution - 0043
NOT_YET_RECRUITING

Seville, 41013, Spain
Local Institution - 0044
NOT_YET_RECRUITING

Helsinki, Etelä-Suomen Lääni, 00290, Finland
Local Institution - 0046
NOT_YET_RECRUITING

Monterrey, Nuevo León, 64040, Mexico
Local Institution - 0048
NOT_YET_RECRUITING

Oaxaca City, 68020, Mexico
Local Institution - 0049
NOT_YET_RECRUITING

Tlalpan, 14080, Mexico
Local Institution - 0052
NOT_YET_RECRUITING

Cali, 760032, Colombia
Local Institution - 0059
NOT_YET_RECRUITING

Dublin, D07 R2WY, Ireland
Local Institution - 0060
NOT_YET_RECRUITING

Vantaa, 01640, Finland
Local Institution - 0061
NOT_YET_RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Local Institution - 0062
NOT_YET_RECRUITING

Dublin, D24 NR0A, Ireland
Local Institution - 0073
NOT_YET_RECRUITING

Milan, 20133, Italy
Local Institution - 0080
NOT_YET_RECRUITING

Boredeaux, 33076, France
Local Institution - 0083
NOT_YET_RECRUITING

Lille, Nord, 59020, France
Local Institution - 0087
NOT_YET_RECRUITING

Napoli Campania, 80131, Italy
Local Institution - 0091
NOT_YET_RECRUITING

Madrid, 28050, Spain
Local Institution - 0095
NOT_YET_RECRUITING

Seattle, Washington, 98109-1023, United States
Local Institution - 0100
NOT_YET_RECRUITING

Iași, 700483, Romania
Local Institution - 0101
NOT_YET_RECRUITING

Sibiu, 550082, Romania
Local Institution - 0103
NOT_YET_RECRUITING

Cluj-Napoca, 400015, Romania
Local Institution - 0105
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 7510032, Chile
Local Institution - 0108
NOT_YET_RECRUITING

Tlalpan, 14080, Mexico
Local Institution - 0109
WITHDRAWN

Montreal, Quebec, H2X 3E4, Canada
Local Institution - 0112
NOT_YET_RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0117
NOT_YET_RECRUITING

New Haven, Connecticut, 06510, United States
Local Institution - 0118
NOT_YET_RECRUITING

Tlalpan, 14080, Mexico
Local Institution - 0122
NOT_YET_RECRUITING

Puebla City, 72424, Mexico
Local Institution - 0126
NOT_YET_RECRUITING

Orlando, Florida, 32803, United States
Local Institution - 0135
NOT_YET_RECRUITING

Cincinnati, Ohio, 45219, United States
Local Institution - 0139
NOT_YET_RECRUITING

Verona, Veneto, 37126, Italy
Local Institution - 0143
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100142, China
Local Institution - 0144
NOT_YET_RECRUITING

Beijing, 100034, China
Local Institution - 0145
NOT_YET_RECRUITING

Tianjin, Hebei, 300060, China
Local Institution - 0147
NOT_YET_RECRUITING

Prague, Praha 5, 150 06, Czechia
Local Institution - 0149
NOT_YET_RECRUITING

Brno, 656 53, Czechia
Local Institution - 0150
NOT_YET_RECRUITING

Hradec Králové, 500 05, Czechia
Local Institution - 0156
NOT_YET_RECRUITING

Buenos Aires, C1199ABB, Argentina
Local Institution - 0157
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 102200, China
Local Institution - 0158
WITHDRAWN

Salt Lake City, Utah, 84112, United States
Local Institution - 0161
NOT_YET_RECRUITING

Craiova, 200347, Romania
Local Institution - 0163
NOT_YET_RECRUITING

Santiago, 8330023, Chile
Local Institution - 0167
NOT_YET_RECRUITING

Seoul, 120-752, South Korea
Local Institution - 0170
NOT_YET_RECRUITING

Fort Wayne, Indiana, 46825, United States
Local Institution - 0175
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Local Institution - 0176
NOT_YET_RECRUITING

Big Rapids, Michigan, 49307, United States
Local Institution - 0177
NOT_YET_RECRUITING

Miami, Florida, 33136, United States
Local Institution - 0178
NOT_YET_RECRUITING

Palo Alto, California, 94305, United States
Local Institution - 0179
NOT_YET_RECRUITING

Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan
Local Institution - 0180
NOT_YET_RECRUITING

Kobe, Hyōgo, 650-0017, Japan
Local Institution - 0181
NOT_YET_RECRUITING

Niigata, 951-8520, Japan
Local Institution - 0182
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510555, China
Local Institution - 0183
NOT_YET_RECRUITING

Changsha Shi, Hunan, 410013, China
Local Institution - 0184
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210008, China
Local Institution - 0186
NOT_YET_RECRUITING

Preston, North West, PR29HT, United Kingdom
Local Institution - 0187
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150081, China
Local Institution - 0188
NOT_YET_RECRUITING

Shanghai Shi, Shanghai Municipality, 200032, China
Local Institution - 0189
NOT_YET_RECRUITING

Edmonton, Alberta, T5M 0V9, Canada
MUSC Hollings Cancer Center
RECRUITING

Charleston, South Carolina, 29425, United States
Macquarie University
RECRUITING

North Ryde, New South Wales, 2109, Australia
Mater Misericordiae Limited
RECRUITING

Brisbane, Queensland, 4101, Australia
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Royal Marsden Hospital (Chelsea)
RECRUITING

London, Kensington and Chelsea, SW3 6JJ, United Kingdom
Royal Marsden Hospital Sutton
RECRUITING

Sulton, Surrey, SM25PT, United Kingdom
Sibley Memorial Hospital
RECRUITING

Washington D.C., District of Columbia, 20016, United States
St Bartholomew's Hospital
RECRUITING

London, London, City of, EC1A 7BE, United Kingdom
The Cancer Institute Hospital of JFCR
RECRUITING

Koto-ku, Tokyo, 135-8550, Japan
The Christie NHS Foundation Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
Toyama University Hospital
RECRUITING

Toyoma, Toyama, 930-0194, Japan
University Of Iowa Hospitals And Clinics
RECRUITING

Iowa City, Iowa, 52242, United States
UniversitätsSpital Zürich
RECRUITING

Zurich, 8091, Switzerland
Velindre Cancer Centre
RECRUITING

Cardiff, CF14 2TL, United Kingdom
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

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