New Antibody-Like drug could boost chemo for rare cancer

NCT ID NCT07544654

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 14 times

Summary

This Phase 3 trial tests whether adding obrixtamig to standard chemotherapy helps people with advanced extrapulmonary neuroendocrine cancer live longer. About 390 adults will be randomly assigned to get either the combo or chemo alone. Obrixtamig is designed to help the immune system target cancer cells. The study also tests a device to measure a tumor marker called DLL3.

What this could mean

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

Active substance: obrixtamig (an antibody-like drug that helps the immune system fight cancer) plus carboplatin and etoposide (standard chemotherapy)
What this could lead to: If it works, this could provide a new first-line treatment option that extends survival for people with advanced extrapulmonary neuroendocrine cancer.
What could go wrong: This is a Phase 3 trial, but it hasn't started yet. The drug may not improve survival over chemo alone, and side effects from the combination could be more severe.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

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

Started

Jul 2026

Expected to finish

Mar 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: 1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \>20% or mitotic rate mitotic rate with number of mitoses \>20 per 2 mm2, regardless of primary site (including site of unknown origin) 2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue 3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease 4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation 5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0) 6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay 7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply. Exclusion Criteria: 1. Presence of leptomeningeal disease and/or carcinomatous meningitis 2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma 3. Patients with neuroendocrine prostate cancer 4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition 5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC) 6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals) 7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0) 8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma neuroendocrine neoplasm

As listed by the trial registrant

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

Extrapulmonary neuroendocrine cancer Extrapulmonary neuroendocrine cancer (epnec) Unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas

How to take part

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

The places running it

167 sites in 29 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

A. O. Universitaria Careggi
NOT_YET_RECRUITING

Florence, 50134, Italy
A.C. Camargo
NOT_YET_RECRUITING

São Paulo, 01509-010, Brazil
Aarhus University Hospital
NOT_YET_RECRUITING

Aarhus N, 8200, Denmark
Addenbrooke's Hospital
NOT_YET_RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Aichi Cancer Center Hospital
NOT_YET_RECRUITING

Aichi, Nagoya, 464-8681, Japan
Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
Asklepios Klinik St Georg
NOT_YET_RECRUITING

Hamburg, 20099, Germany
Auckland City Hospital
NOT_YET_RECRUITING

Grafton / Auckland, 1023, New Zealand
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
NOT_YET_RECRUITING

Palermo, 90129, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
NOT_YET_RECRUITING

Bari, 70124, Italy
Baylor University Medical Center
NOT_YET_RECRUITING

Dallas, Texas, 75246, United States
Beijing Cancer Hospital
RECRUITING

Beijing, 100142, China
Beijing GoBroad Hospital
RECRUITING

Beijing, 102200, China
Bradford Hill- Centro de Investigacion Clinica
NOT_YET_RECRUITING

Recoleta, 8420383, Chile
CTR Eugène Marquis
NOT_YET_RECRUITING

Rennes, 35042, France
Centre Hospitalier Universitaire de Liège
RECRUITING

Liège, 4000, Belgium
Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente
NOT_YET_RECRUITING

Guadalajara, Jalisco, 44329, Mexico
Centro Medico Reumatologico - OMI
RECRUITING

CABA, 1015, Argentina
Centro Oncologico Estatal ISSEMYM
RECRUITING

Toluca, 50180, Mexico
Centro Oncologico Personalizado
NOT_YET_RECRUITING

México, 06760, Mexico
Centro Ricerche Cliniche di Verona S.r.l.
NOT_YET_RECRUITING

Verona, 37134, Italy
Chang Gung Memorial Hospital, Linkou
RECRUITING

Taoyuan City, 333, Taiwan
Chongqing University Affiliated Cancer Hospital
RECRUITING

Chongqing, 400000, China
City of Hope-Duarte-56419
RECRUITING

Duarte, California, 91010, United States
Clinica Alemana de Santiago S.A.
NOT_YET_RECRUITING

Santiago, 7650568, Chile
Clinica Privada Independencia
RECRUITING

Munro, B1605, Argentina
Cliniques Universitaires Saint-Luc
RECRUITING

Brussels, 1200, Belgium
Complejo Hospitalario de Navarra
NOT_YET_RECRUITING

Pamplona, 31008, Spain
DRK Kliniken Berlin Köpenick
NOT_YET_RECRUITING

Berlin, 12559, Germany
Dana-Farber Cancer Institute
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Erasmus Medisch Centrum
NOT_YET_RECRUITING

Rotterdam, 3015 GD, Netherlands
Fiona Stanley Hospital
RECRUITING

Murdoch, Western Australia, 6150, Australia
First Affiliated Hospital of Xi'an JiaoTong University
NOT_YET_RECRUITING

Xi'an, 710061, China
First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING

Xiamen, 361003, China
Flinders Medical Centre
RECRUITING

Bedford Park, South Australia, 5042, Australia
Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Campus Bio-medico
NOT_YET_RECRUITING

Roma, 00128, Italy
Fred Hutchinson Cancer Research Center
NOT_YET_RECRUITING

Seattle, Washington, 98109, United States
Fujian Cancer Hospital
NOT_YET_RECRUITING

Fuzhou, 350014, China
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING

São José do Rio Preto, 15090-000, Brazil
HOP François Mitterrand
NOT_YET_RECRUITING

Dijon, 21000, France
HOP Haut-Lévêque
NOT_YET_RECRUITING

Pessac, 33604, France
Hadassah Medical Center, Ein-Karem
NOT_YET_RECRUITING

Jerusalem, 9112001, Israel
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, 150081, China
Haukeland Universitetssykehus
NOT_YET_RECRUITING

Bergen, 5021, Norway
Health Pharma Professional Research S.A. de C.V.
NOT_YET_RECRUITING

Mexico City, 03100, Mexico
Helse Stavanger, Stavanger Universitetssykehus
NOT_YET_RECRUITING

Stavanger, 4011, Norway
Helsinki University Hospital
NOT_YET_RECRUITING

Helsinki, 00290, Finland
Hokkaido University Hospital
RECRUITING

Hokkaido, Sapporo, 060-8648, Japan
Hospital Britanico de Buenos Aires
RECRUITING

CABA, 1280AEB, Argentina
Hospital CUF Porto
NOT_YET_RECRUITING

Porto, 4100-180, Portugal
Hospital Clinico De Valencia (INCLIVA)
NOT_YET_RECRUITING

Valencia, 46010, Spain
Hospital Lusiadas Lisboa
RECRUITING

Lisbon, 1500-458, Portugal
Hospital Regional Universitario de Malaga
NOT_YET_RECRUITING

Málaga, 29010, Spain
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING

Madrid, 28041, Spain
Hospital Universitario Fundacion Jimenez Diaz
NOT_YET_RECRUITING

Madrid, 28040, Spain
Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITING

Santander, 39008, Spain
Hospital Universitario Ramon Y Cajal
NOT_YET_RECRUITING

Madrid, 28034, Spain
Hospital Virgen del Rocio
NOT_YET_RECRUITING

Seville, 41013, Spain
Hospital de Amor
RECRUITING

Barretos, 14784-400, Brazil
Hubei Cancer Hospital
RECRUITING

Wuhan, 430000, China
Hunan Province Tumor Hospital
NOT_YET_RECRUITING

Changsha, 410013, China
Huntsman Cancer Institute
NOT_YET_RECRUITING

Salt Lake City, Utah, 84112, United States
Hôpital Beaujon
RECRUITING

Clichy, 92110, France
Hôpital Edouard Herriot
NOT_YET_RECRUITING

Lyon, 69437, France
Hôpital Rangueil - CHU de Toulouse
NOT_YET_RECRUITING

Toulouse, 31059, France
ICESP - Instituto do Cancer do Estado de Sao Paulo
NOT_YET_RECRUITING

São Paulo, 01246-000, Brazil
INS Paoli-Calmettes
NOT_YET_RECRUITING

Marseille, 13009, France
IPO Lisboa Francisco Gentil, EPE
NOT_YET_RECRUITING

Lisbon, 1099-023, Portugal
IPO Porto Francisco Gentil, EPE
RECRUITING

Porto, 4200-072, Portugal
Institut Català d'Oncologia de Badalona
NOT_YET_RECRUITING

Badalona, 8916, Spain
Institut Gustave Roussy
RECRUITING

Villejuif, 94800, France
Instituto D'Or de Pesquisa E Ensino - Pe
NOT_YET_RECRUITING

Recife, 50070-480, Brazil
Instituto Jaliciense de Cancerología
NOT_YET_RECRUITING

Zapopan, 45060, Mexico
Instituto Oncologico FALP
NOT_YET_RECRUITING

Providencia, Chile
Istituto Europeo di Oncologia
NOT_YET_RECRUITING

Milan, 20141, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
NOT_YET_RECRUITING

Naples, 80131, Italy
KYS Sädesairaala
NOT_YET_RECRUITING

Kuopio, 70029, Finland
Kanagawa Cancer Center
NOT_YET_RECRUITING

Kanagawa, Yokohama, 241-8515, Japan
Kanazawa University Hospital
NOT_YET_RECRUITING

Ishikawa, Kanazawa, 920-8641, Japan
Kyoto University Hospital
NOT_YET_RECRUITING

Kyoto, Kyoto, 606-8507, Japan
Kyushu University Hospital
RECRUITING

Fukuoka, Fukuoka, 812-8582, Japan
Linyi Cancer Hospital
RECRUITING

Linyi, 276034, China
Maastricht University Medisch Centrum
NOT_YET_RECRUITING

Maastricht, 6229 HX, Netherlands
Masaryk Memorial Cancer Institute
NOT_YET_RECRUITING

Brno, 65653, Czechia
Mayo Clinic
NOT_YET_RECRUITING

Scottsdale, Arizona, 85259, United States
Mayo Clinic - Florida
NOT_YET_RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic, Rochester
NOT_YET_RECRUITING

Rochester, Minnesota, 55905, United States
Medical University Gdansk
NOT_YET_RECRUITING

Gdansk, 80-214, Poland
Medical University of Graz
NOT_YET_RECRUITING

Graz, 8036, Austria
Medical University of Vienna
NOT_YET_RECRUITING

Vienna, 1090, Austria
Memorial Sloan-Kettering Cancer Center
NOT_YET_RECRUITING

New York, New York, 10022, United States
National Cancer Center Hospital
RECRUITING

Tokyo, Chuo-ku, 104-0045, Japan
National Cancer Center Hospital East
NOT_YET_RECRUITING

Chiba, Kashiwa, 277-8577, Japan
National Cheng Kung University Hospital
RECRUITING

Tainan, 70403, Taiwan
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
NOT_YET_RECRUITING

Amsterdam, 1066CX, Netherlands
Odense University Hospital
NOT_YET_RECRUITING

Odense C, 5000, Denmark
Okayama University Hospital
NOT_YET_RECRUITING

Okayama, Okayama, 700-8558, Japan
Osaka International Cancer Institute
NOT_YET_RECRUITING

Osaka, Osaka, 541-8567, Japan
Oslo Universitetssykehus HF, Radiumhospitalet
NOT_YET_RECRUITING

Oslo, N-0379, Norway
Peter MacCallum Cancer Centre
RECRUITING

Melbourne, Victoria, 3000, Australia
Prince of Wales Hospital-Hong Kong-20715
RECRUITING

Hong Kong, 999077, Hong Kong
Qilu Hospital, Shangdong University
RECRUITING

Jinan, 250012, China
Queen Mary Hospital
RECRUITING

Hong Kong, 999077, Hong Kong
Rambam Health Care Campus
NOT_YET_RECRUITING

Haifa, 3109601, Israel
Rigshospitalet
NOT_YET_RECRUITING

Copenhagen, 2100, Denmark
Royal North Shore Hospital
NOT_YET_RECRUITING

St Leonards, New South Wales, 2065, Australia
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sahlgrenska Universitetsjukhuset
NOT_YET_RECRUITING

Gothenburg, 41345, Sweden
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Sanatorio Parque S.A.
RECRUITING

Rosario, S2000DSV, Argentina
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital
RECRUITING

Seoul, 03722, South Korea
Shandong Cancer Hospital
RECRUITING

Jinan, 250117, China
Shanghai General Hospital
RECRUITING

Shanghai, 200080, China
Shikoku Cancer Center
RECRUITING

Ehime, Matsuyama, 791-0280, Japan
Shizuoka Cancer Center
NOT_YET_RECRUITING

Shizuoka, Sunto-gun, 411-8777, Japan
Sichuan Cancer Hospital
RECRUITING

Chengdu, 610041, China
Silesian Medical University in Katowice
NOT_YET_RECRUITING

Katowice, 40514, Poland
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
RECRUITING

Hangzhou, 310016, China
Skånes universitetssjukhus
NOT_YET_RECRUITING

Lund, 22185, Sweden
Soroka Univ. Medical Center
NOT_YET_RECRUITING

Beersheba, 84101, Israel
Sourasky Medical Center
NOT_YET_RECRUITING

Tel Aviv, 6093246, Israel
St. Olavs Hospital, Universitetssykehuset i Trondheim
NOT_YET_RECRUITING

Trondheim, 7030, Norway
Sunnybrook Health Sciences Centre
NOT_YET_RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Taipei Veterans General Hospital
RECRUITING

Taipei, 112201, Taiwan
Tampere University Hospital
NOT_YET_RECRUITING

Tampere, 33520, Finland
Technische Universität Dresden
NOT_YET_RECRUITING

Dresden, 01307, Germany
The Affiliated Cancer Hospital, Guangxi Medical University
RECRUITING

Nanning, 530021, China
The Christie Hospital
RECRUITING

Manchester, M20 4BX, United Kingdom
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING

Luoyang, 471003, China
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, 450052, China
The First Affiliated Hospital,Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, 510080, China
The First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, 130021, China
The Ohio State University Wexner Medical Center
NOT_YET_RECRUITING

Columbus, Ohio, 43221, United States
The Skip Viragh Outpatient Cancer Research Building
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
The University of Chicago Medical Center
NOT_YET_RECRUITING

Chicago, Illinois, 60637, United States
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
Tohoku University Hospital
NOT_YET_RECRUITING

Miyagi, Sendai, 980-8574, Japan
Turku University Hospital / TYKS
NOT_YET_RECRUITING

Turku, 20520, Finland
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
Unidade Local de Saúde Santa Maria
NOT_YET_RECRUITING

Lisbon, 1699-035, Portugal
Universitair Medisch Centrum Groningen
NOT_YET_RECRUITING

Groningen, 9713 GZ, Netherlands
Universitair Ziekenhuis Antwerpen
RECRUITING

Edegem, 2650, Belgium
University Hospital Hradec Kralove (FNHK)
NOT_YET_RECRUITING

Hradec Králové, 50005, Czechia
University of California Los Angeles
NOT_YET_RECRUITING

Santa Monica, California, 90404, United States
University of California San Francisco
NOT_YET_RECRUITING

San Francisco, California, 94158, United States
University of Pittsburgh Medical Center
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Tennessee
RECRUITING

Knoxville, Tennessee, 37920, United States
Universitätsklinikum Bonn AöR
NOT_YET_RECRUITING

Bonn, 53127, Germany
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING

Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen
NOT_YET_RECRUITING

Erlangen, 91054, Germany
Universitätsklinikum Freiburg
NOT_YET_RECRUITING

Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Heidelberg
NOT_YET_RECRUITING

Heidelberg, 69120, Germany
Universitätsklinikum Köln (AöR)
NOT_YET_RECRUITING

Cologne, 50937, Germany
Universitätsklinikum Tübingen
NOT_YET_RECRUITING

Tübingen, 72076, Germany
Universitätsklinikum Würzburg AÖR
NOT_YET_RECRUITING

Würzburg, 97078, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
NOT_YET_RECRUITING

Mainz, 55131, Germany
Uppsala University Hospital
NOT_YET_RECRUITING

Uppsala, 751 85, Sweden
Vanderbilt-Ingram Cancer Center
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63108, United States
West China Hospital, Sichuan University
RECRUITING

Chengdu, 610041, China
Western General Hospital
NOT_YET_RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Westfälische Wilhelms-Universität Münster
NOT_YET_RECRUITING

Münster, 48149, Germany
Xiangya Hospital, Central South University
NOT_YET_RECRUITING

Changsha, 410008, China

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