Sponsor: Bristol-Myers Squibb (industry)
Phase: 2/3
Start date: Oct. 27, 2025
Planned enrollment: 690
Pumitamig (BNT327, formerly PM8002) is an investigational cancer drug being studied alone and with chemotherapy across several solid tumors. DB-1305 is not another name for pumitamig: it is a separate antibody–drug conjugate, also called BNT325, that has been studied in combination with BNT327. (biontechse.gcs-web.com)
Pumitamig is a bispecific antibody targeting PD-L1 and VEGF-A. It is designed to combine immune-checkpoint inhibition with blockade of VEGF-A signaling. (biontechse.gcs-web.com)
Human results are available, but the findings below are from early-phase studies; the response rates do not establish a benefit over standard treatment.
In the lung-cancer combination trial, 19 of 43 patients (44.2%) had grade 3 or higher treatment-related adverse events; 8 (18.6%) had events considered related to pumitamig. Pumitamig-related events led to discontinuation in 2 patients (4.7%). In the cervical/ovarian monotherapy cohorts, 31 of 87 patients (35.6%) had grade 3 or higher treatment-related adverse events, and 13 (14.9%) discontinued treatment because of such events. Commonly reported events in those cohorts included protein in the urine and high blood pressure. These figures come from different studies and treatment regimens and should not be compared directly. (asco.org)
Last updated: Sep 2026
Goal: Evaluate whether pumitamig plus chemotherapy improves efficacy while maintaining acceptable safety compared with nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Patients: Adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma that is HER2-negative, has documented PD-L1 ≥1, and is measurable by RECIST v1.1. Key exclusions include untreated known CNS metastases and significant cardiovascular, clotting, or recent gastrointestinal complications.
Design: Blinded, randomized phase 2/3 comparison. Phase 2 evaluates response and selects a pumitamig dose; phase 3 evaluates progression-free and overall survival.
Treatments: Pumitamig is combined with FOLFOX in the phase 2 arms and with FOLFOX or CAPOX in the phase 3 arm; comparator arms receive nivolumab with FOLFOX or CAPOX. Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A, designed to combine checkpoint inhibition with antiangiogenic activity. Early studies in other cancers have shown responses, including 28 of 40 evaluable patients with untreated advanced non-small-cell lung cancer receiving pumitamig plus chemotherapy, but these findings do not establish benefit in gastric or esophageal cancer. Nivolumab is a PD-1 inhibitor used here with platinum-fluoropyrimidine chemotherapy.
Outcomes: The phase 2 primary endpoint is investigator-assessed confirmed objective response. Phase 3 primary endpoints are blinded independent central review–assessed progression-free survival and overall survival. Secondary measures include response duration, time to response, disease control, and selection of the phase 3 pumitamig dose.
Burden on patient: Moderate, based on repeated visits for intravenous treatment, blood tests, and imaging to assess response and progression over potentially prolonged follow-up. The supplied information does not specify mandatory research biopsies, intensive pharmacokinetic sampling, or visit frequency, so any additional burden beyond routine chemotherapy and immunotherapy care is uncertain.
Last updated: Sep 2026
Inclusion Criteria
* Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
* Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
* Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
* Participants must have measurable disease as defined by RECIST v1.1.
Exclusion Criteria
* Participants must not have untreated known central nervous system (CNS) metastases.
* Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
* Participants must not have evidence of major coagulation disorders (eg, hemophilia).
* Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
* Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
* Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Elizabeth Vale, South Australia, 5112, Australia
No email / 0881829000
Status: Recruiting
Beijing, Beijing Municipality, 100142, China
No email / 13911219511
Status: Recruiting
Suita, Osaka, 565-0871, Japan
No email / 81668795111
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Chuo-ku, Tokyo, 104-0045, Japan
No email / 81335422511
Status: Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
No email / 82230105935
Status: Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
No email / 82222288050
Status: Recruiting
Manchester, M20 4BX, United Kingdom
No email / 447710630514
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St. Petersburg, Florida, 33701, United States
No email / 000-000-0000
Status: Recruiting
Fort Myers, Florida, 33901, United States
No email / 239-274-9930
Status: Recruiting
Columbia, Missouri, 65201, United States
No email / 573-874-7800
Status: Recruiting
Lake Success, New York, 11042, United States
No email / 323-533-7275
Status: Recruiting
Portland, Oregon, 97213-2982, United States
No email / 503-528-5005
Status: Recruiting
Eugene, Oregon, 97401, United States
No email / 541-214-8284
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Nashville, Tennessee, 37203, United States
No email / 615-986-4366
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Beaumont, Texas, 77702, United States
No email / No phone
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Amarillo, Texas, 79124, United States
No email / 325-692-0188
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Grapevine, Texas, 76051, United States
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Denison, Texas, 75020, United States
No email / 000-000-0000
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San Antonio, Texas, 78240, United States
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Austin, Texas, 78731, United States
No email / 512-427-9400
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Salem, Virginia, 24153, United States
No email / 540-982-0237
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Buenos Aires, C1431FWO, Argentina
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Buenos Aires, 1039, Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
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ABB, Buenos Aires F.D., C1199ABB, Argentina
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Liverpool, New South Wales, 2170, Australia
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Birtinya, Queensland, 4575, Australia
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Clayton, Victoria, 3168, Australia
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Melbourne, Victoria, 3084, Australia
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Perth, Western Australia, 6150, Australia
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São José do Rio Preto, 15090-000, Brazil
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Fortaleza, Ceará, 60115-280, Brazil
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Belo Horizonte, Minas Gerais, 30140-073, Brazil
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Natal/RN, Rio Grande do Norte, 59062-000, Brazil
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Porto Alegre, Rio Grande do Sul, 80035-903, Brazil
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Santa Maria, Rio Grande do Sul, 97015-373, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Santiago, Santiago Metropolitan, 8420383, Chile
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Santiago, Santiago Metropolitan, 7710007, Chile
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Santiago, Santiago Metropolitan, 7500921, Chile
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Shanghai, 200032, China
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Fuzhou, Fujian, 350014, China
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Guangzhou, Guangdong, 510000, China
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Guangzhou, Guangdong, 510655, China
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Nanning, Guangxi, 530021, China
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Harbin, Heilongjiang, 150081, China
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Zhengzhou, Henan, 450008, China
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Weihui, Henan, 453100, China
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Wuhan, Hubei, 430079, China
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Changsha, Hunan, 410031, China
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Nanjing, Jiangsu, 210009, China
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Nanchang, Jiangxi, 330006, China
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Shenyang, Liaoning, 110042, China
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Jinan, Shandong, 250117, China
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Shanghai, Shanghai Municipality, 200120, China
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Taiyuan, Shanxi, 030001, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 300060, China
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Hangzhou, Zhejiang, 310052, China
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Hangzhou, Zhejiang, 310003, China
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Pasto, Departamento de Nariño, 520001, Colombia
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Cali, Valle del Cauca Department, 760032, Colombia
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Poitiers, 86021, France
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Paris, 75015, France
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Lille, 59037, France
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Lyon, 69373, France
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Marseille, 13009, France
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Brest, Finistère, 29200, France
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Nantes, Pays de la Loire Region, 44093, France
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Berlin, 10117, Germany
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Hamburg, 20249, Germany
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Heidelberg, 69120, Germany
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Mannheim, 68167, Germany
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Mainz, 55131, Germany
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Leipzig, 04103, Germany
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Ulm, 89081, Germany
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Frankfurt, 60488, Germany
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Puducherry, 605006, India
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Delhi, 110029, India
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Pune, 411001, India
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Delhi, 110029, India
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Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001, India
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Mumbai, Maharashtra, 400012, India
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Mumbai, Maharashtra, 400036, India
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Milan, 20133, Italy
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Padova, 35128, Italy
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Roma, 00168, Italy
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Milan, 20132, Italy
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Naples, Campania, 80138, Italy
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Turin, Piedmont, 10126, Italy
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Minami-Ku, Fukuoka, 811-1347, Japan
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Gifu, 501-1194, Japan
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Chikusa-ku, 464-8681, Japan
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Sendai, 980-8574, Japan
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Kashiwa, 277-8577, Japan
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Chiba, Chiba, 260-8717, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Yokohama, Kanagawa, 2418515, Japan
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Kurashiki, Okayama-ken, 710-8602, Japan
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Osaka, Osaka, 5418567, Japan
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Takatsuki, Osaka, 569-8686, Japan
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Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan
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Koto-ku, Tokyo, 1358550, Japan
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Mexico City, DIF, 03100, Mexico
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Mexico City, Mexico City, 14000, Mexico
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Mexico City, Mexico City, 14000, Mexico
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Oaxaca City, Oaxaca, 68020, Mexico
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Status: Not yet recruiting
Opole, 45-372, Poland
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Status: Not yet recruiting
Krakow, 31-115, Poland
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Krakow, 31-115, Poland
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Status: Not yet recruiting
Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
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Status: Not yet recruiting
Wieliszew, Masovian Voivodeship, 05-135, Poland
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Status: Not yet recruiting
Iași, 700483, Romania
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Status: Not yet recruiting
Craiova, 200347, Romania
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Status: Not yet recruiting
Cluj-Napoca, 400015, Romania
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Status: Not yet recruiting
Iași, 700106, Romania
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Floresti/ Cluj, 407280, Romania
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Status: Not yet recruiting
Cluj-Napoca, Cluj, 400162, Romania
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Seongnam, Kyǒnggi-do, 13620, South Korea
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Status: Not yet recruiting
Seoul, Seoul Teugbyeolsi, 03080, South Korea
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Status: Not yet recruiting
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
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Status: Not yet recruiting
Madrid, 28040, Spain
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Status: Not yet recruiting
Madrid, 28046, Spain
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Status: Not yet recruiting
Madrid, 28028, Spain
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Málaga, 29011, Spain
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Barcelona, Barcelona [Barcelona], 08035, Spain
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Santander, Cantabria, 39008, Spain
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Pamplona, Navarre, 31009, Spain
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Valencia, Valenciana, Comunitat, 46010, Spain
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Status: Not yet recruiting
Manisa, 45030, Turkey (Türkiye)
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Status: Not yet recruiting
Edirne, 22030, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Ankara, 06230, Turkey (Türkiye)
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Status: Not yet recruiting
Kadiköy/Istanbul, 41380, Turkey (Türkiye)
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Status: Not yet recruiting
Sakarya, 0, Turkey (Türkiye)
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Status: Not yet recruiting
Glasgow, G12 0YN, United Kingdom
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Status: Not yet recruiting
Sutton, SM2 5PT, United Kingdom
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Status: Not yet recruiting
London, London, City of, EC1A 7BE, United Kingdom
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Status: Not yet recruiting
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
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Status: Not yet recruiting
Phoenix, Arizona, 85054, United States
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Status: Not yet recruiting
Orange, California, 92868, United States
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San Francisco, California, 94158, United States
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Status: Not yet recruiting
Los Angeles, California, 90033, United States
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Jacksonville, Florida, 32224, United States
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Atlanta, Georgia, 30308, United States
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Status: Not yet recruiting
Chicago, Illinois, 60637, United States
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Status: Not yet recruiting
Iowa City, Iowa, 52242, United States
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Status: Not yet recruiting
Rochester, Minnesota, 55905, United States
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Status: Not yet recruiting
Omaha, Nebraska, 68198, United States
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Status: Not yet recruiting
New York, New York, 10021, United States
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Status: Not yet recruiting
Rochester, New York, 14642, United States
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Status: Not yet recruiting
Chapel Hill, North Carolina, 27599, United States
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Status: Not yet recruiting
Cleveland, Ohio, 44195, United States
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Status: Not yet recruiting
Pittsburgh, Pennsylvania, 15213, United States
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Status: Not yet recruiting
Nashville, Tennessee, 37203, United States
No email / No phone
Status: Not yet recruiting
Houston, Texas, 77030, United States
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Status: Not yet recruiting
Madison, Wisconsin, 53792, United States
No email / No phone
Status: Not yet recruiting
Tampa, Florida, 33612, United States
No email / No phone
Status: Withdrawn