ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Bookmark
Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Bristol-Myers Squibb (industry)

Phase: 2/3

Start date: Oct. 27, 2025

Planned enrollment: 690

Trial ID: NCT07221149
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: BNT327 (Pumitamig, PM8002, DB-1305)

TrialFetch AI Analysis

Goal: To compare the safety and antitumor efficacy of pumitamig plus platinum/fluoropyrimidine chemotherapy versus nivolumab plus platinum/fluoropyrimidine chemotherapy as first-line treatment for advanced or metastatic upper GI adenocarcinoma.

Patients: Adults with previously untreated, histologically/cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma; HER2-negative disease; PD-L1 expression ≥1; and measurable disease per RECIST v1.1. Key exclusions include untreated CNS metastases, significant recent cardiovascular events or uncontrolled hypertension, major coagulation disorders or recent significant thromboembolism, recent GI perforation/fistula, and recent major surgery/trauma.

Design: Blinded, randomized, industry-sponsored phase 2/3 study (planned enrollment 690). The phase 2 portion evaluates activity and helps determine the recommended pumitamig dose for phase 3; the phase 3 portion tests progression-free survival and overall survival, with radiographic endpoints assessed both by investigators and by blinded independent central review.

Treatments: Participants are randomized to receive pumitamig plus chemotherapy or nivolumab plus chemotherapy, using standard first-line platinum/fluoropyrimidine backbones (FOLFOX and/or CAPOX per protocol arm). Pumitamig (BNT327/PM8002) is an investigational bispecific antibody that targets PD-L1 and VEGF-A, combining checkpoint blockade with anti-angiogenic inhibition to enhance antitumor immunity and modify the tumor microenvironment. Early phase studies in other solid tumors have reported high response rates when combined with chemotherapy (for example, ORR ~55% after EGFR-TKI failure in EGFR-mutant NSCLC and ORR >80% in extensive-stage SCLC), with a generally manageable toxicity profile that includes expected chemotherapy-related cytopenias alongside immune-related and VEGF-pathway adverse events. Nivolumab is an anti–PD-1 antibody and an established component of first-line therapy with fluoropyrimidine/platinum chemotherapy in PD-L1–positive, HER2-negative gastroesophageal adenocarcinoma.

Outcomes: Phase 2 primary endpoint is investigator-assessed objective response rate (confirmed CR/PR) by RECIST v1.1. Phase 3 primary endpoints are progression-free survival by RECIST v1.1 per blinded independent central review and overall survival. Key secondary endpoints include investigator-assessed PFS, duration of response, time to response, and disease control; confirmation of response and duration by blinded independent central review; and determination of the recommended pumitamig dose for phase 3.

Burden on patient: Moderate burden. Treatment requires regular IV infusions of biologic therapy plus multi-agent chemotherapy with routine safety labs and monitoring typical of first-line metastatic regimens, and serial tumor imaging for RECIST assessments through approximately 33 months (and survival follow-up longer). Blinded independent central review implies standardized imaging submission but usually does not add procedures beyond scheduled scans. No mandatory research biopsies or intensive phase 1-style pharmacokinetic sampling are described, which limits additional burden beyond standard-of-care chemoimmunotherapy monitoring.

Last updated: Feb 2026

Eligibility More information

chevron Show Criteria

Sites (161)

Sort by distance to:
Clear

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

No email / 573-874-7800

Status: Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

No email / 615-986-4366

Status: Recruiting

Texas Oncology-Austin Central

Austin, Texas, 78731, United States

No email / 512-427-9400

Status: Recruiting

Local Institution - 0054

Buenos Aires, C1431FWO, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0069

Buenos Aires, 1039, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0061

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0066

ABB, Buenos Aires F.D., C1199ABB, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0080

Birtinya, Queensland, 4575, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0077

Elizabeth Vale, South Australia, 5112, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0085

Clayton, Victoria, 3168, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0400

Melbourne, Victoria, 3084, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0083

Perth, Western Australia, 6150, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0221

São José do Rio Preto, 15090-000, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0208

Fortaleza, Ceará, 60115-280, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0204

Belo Horizonte, Minas Gerais, 30140-073, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0226

Natal/RN, Rio Grande do Norte, 59062-000, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0210

Porto Alegre, Rio Grande do Sul, 80035-903, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0425

Santa Maria, Rio Grande do Sul, 97015-373, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0088

Calgary, Alberta, T2N 5G2, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0119

Halifax, Nova Scotia, B3H 3A7, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0121

Toronto, Ontario, M5G 2M9, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0175

Sherbrooke, Quebec, J1H 5N4, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0055

Santiago, Santiago Metropolitan, 8420383, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0056

Santiago, Santiago Metropolitan, 7710007, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0068

Santiago, Santiago Metropolitan, 7500921, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0269

Shanghai, 200032, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0410

Beijing, Beijing Municipality, 100034, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0418

Beijing, Beijing Municipality, 100142, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0276

Fuzhou, Fujian, 350014, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0232

Guangzhou, Guangdong, 510000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0280

Guangzhou, Guangdong, 510655, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0231

Nanning, Guangxi, 530021, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0237

Harbin, Heilongjiang, 150081, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0249

Zhengzhou, Henan, 450008, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0282

Weihui, Henan, 453100, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0279

Wuhan, Hubei, 430079, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0412

Wuhan, Hubei, 430022, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0292

Changsha, Hunan, 410031, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0409

Nanchang, Jiangxi, 330006, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0244

Shenyang, Liaoning, 110042, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0239

Xi'an, Shaanxi, 710061, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0266

Xi'an, Shaanxi, 710126, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0273

Jinan, Shandong, 250117, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0258

Shanghai, Shanghai Municipality, 200120, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0243

Taiyuan, Shanxi, 030001, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0260

Chengdu, Sichuan, 610041, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0248

Tianjin, Tianjin Municipality, 300060, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0252

Hangzhou, Zhejiang, 310052, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0408

Hangzhou, Zhejiang, 310003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0399

Pasto, Departamento de Nariño, 520001, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0398

Cali, Valle del Cauca Department, 760032, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0046

Poitiers, 86021, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0049

Paris, 75015, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0051

Lille, 59037, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0058

Lyon, 69373, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0060

Marseille, 13009, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0064

Brest, Finistère, 29200, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0062

Nantes, Pays de la Loire Region, 44093, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0089

Berlin, 10117, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0090

Hamburg, 20249, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0100

Heidelberg, 69120, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0101

Mannheim, 68167, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0105

Mainz, 55131, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0112

Leipzig, 04103, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0117

Ulm, 89081, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0134

Frankfurt, 60488, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0302

Puducherry, 605006, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0303

Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0310

Pune, 411001, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0403

Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0306

Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0305

Mumbai, Maharashtra, 400012, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0404

Mumbai, Maharashtra, 400036, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0163

Milan, 20133, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0168

Padua, 35128, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0170

Roma, 00168, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0171

Milan, 20132, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0167

Napoli, Campania, 80138, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0166

Turin, Piedmont, 10126, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0002

Minami-Ku, Fukuoka, 811-1347, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0006

Gifu, 501-1194, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0013

Chikusa-ku, 464-8681, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0015

Yokohama, 101-0047, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0024

Sendai, 980-8574, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0033

Kashiwa, 277-8577, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0014

Chiba, Chiba, 2608717, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0012

Matsuyama, Ehime, 791-0280, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0029

Kurashiki, Okayama-ken, 710-8602, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0004

Osaka, Osaka, 5418567, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0028

Suita, Osaka, 565-0871, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0376

Takatsuki, Osaka, 569-8686, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0026

Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0003

Chuo-ku, Tokyo, 104-0045, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0008

Koto-ku, Tokyo, 1358550, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0396

Mexico City, DIF, 03100, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0395

Mexico City, Mexico City, 14000, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0397

Mexico City, Mexico City, 14000, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0394

Oaxaca City, Oaxaca, 68020, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0320

Opole, 45-372, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0342

Krakow, 31-115, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0361

Krakow, 31-115, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0336

Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0339

Wieliszew, Masovian Voivodeship, 05-135, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0005

Iași, 700483, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0011

Craiova, 200347, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0019

Cluj-Napoca, 400015, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0021

Iași, 700106, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0030

Floresti/ Cluj, 407280, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0010

Cluj-Napoca, Cluj, 400162, Romania

No email / No phone

Status: Not yet recruiting

Local Institution - 0034

Seongnam, Kyǒnggi-do, 13620, South Korea

No email / No phone

Status: Not yet recruiting

Local Institution - 0027

Seoul, Seoul Teugbyeolsi, 03080, South Korea

No email / No phone

Status: Not yet recruiting

Local Institution - 0036

Seoul, Seoul-teukbyeolsi, 05505, South Korea

No email / No phone

Status: Not yet recruiting

Local Institution - 0001

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

No email / No phone

Status: Not yet recruiting

Local Institution - 0020

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

No email / No phone

Status: Not yet recruiting

Local Institution - 0358

Madrid, 28040, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0360

Madrid, 28046, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0389

Madrid, 28028, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0390

Málaga, 29011, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0350

Santander, Cantabria, 39008, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0391

Pamplona, Navarre, 31009, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0312

Valencia, Valenciana, Comunitat, 46010, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0093

Manisa, 45030, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0108

Edirne, 22030, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0111

Ankara, 06230, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0125

Kadiköy/Istanbul, 41380, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0128

Sakarya, 0, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0354

Glasgow, G12 0YN, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0357

Sutton, SM2 5PT, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0176

Southampton, Hampshire, SO16 0YD, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0331

Manchester, Lancashire, M20 4BX, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0316

London, London, City of, EC1A 7BE, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0317

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

No email / No phone

Status: Not yet recruiting

Local Institution - 0284

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0240

Los Angeles, California, 90095, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0277

Orange, California, 92868, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0428

San Francisco, California, 94158, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0429

Fort Myers, Florida, 33901, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0430

St. Petersburg, Florida, 33705, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0433

Jacksonville, Florida, 32224, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0377

Atlanta, Georgia, 30308, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0379

Chicago, Illinois, 60637, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0268

Iowa City, Iowa, 52242, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0259

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0286

Omaha, Nebraska, 68198, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0242

New York, New York, 10021, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0274

Rochester, New York, 14642, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0386

Lake Success, New York, 11042, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0222

Cleveland, Ohio, 44195, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0419

Portland, Oregon, 97213, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0432

Eugene, Oregon, 97401, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0407

Pittsburgh, Pennsylvania, 15213, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0255

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0233

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0415

Denison, Texas, 75020, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0421

Grapevine, Texas, 76051, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0423

Amarillo, Texas, 79124, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0424

Beaumont, Texas, 77701, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0427

San Antonio, Texas, 78229, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0413

Salem, Virginia, 24153, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0271

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0246

Tampa, Florida, 33612, United States

No email / No phone

Status: Withdrawn

Back to trials list