New drug combo tested for tough cancers
NCT ID NCT05599984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests an investigational drug called ABBV-706, alone or combined with other drugs, in about 288 adults with advanced solid tumors like small cell lung cancer, high-grade brain tumors, and neuroendocrine cancers. The main goals are to check safety, find the right dose, and see if the drug shrinks tumors. Participants will receive the drug through an IV and will be closely monitored with frequent blood tests and scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABBV-706 (an investigational drug) given alone or with budigalimab, carboplatin, or cisplatin
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced small cell lung cancer, high-grade brain tumors, or neuroendocrine cancers.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not work or could have serious side effects. It is also a small study, so results may not apply to everyone.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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288 people
The number who actually took part.
- Started
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Dec 2022
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * The laboratory values criteria must be met within 7 days prior to the first dose of study drug as per the protocol. * QT interval corrected for heart rate (QTc) \<= 450 msec (males) or \<= 470 msec (females) using Fridericia's correction, and an ejection fraction of \>= 50% as measured by echocardiogram or multigated acquisition (MUGA) scan at Screening. * Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6 expression including small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors (glioblastoma \[GBM\], IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4), neuroendocrine prostate cancer (NEPC), high-grade poorly differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cell neuroendocrine carcinoma (LCNEC)s, SCLC transformed from epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids, and other high-grade poorly differentiated NECs, who have progressed on or after standard of care (SoC) therapy and with no curative therapy available. For SCLC, participants must have histologically or cytologically confirmed SCLC that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy. * Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed or refractory (R/R) following at least 1 prior platinum-containing chemotherapy and with no curative therapy available. For the purposes of this study, a line of therapy is defined as \>= 1 complete cycle of either a single agent or combination of drugs, including any planned sequential therapy of various regimens. * Part 3a only: SCLC or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed) * Part 3b only: SCLC who have only progressed following a frontline regimen containing a platinum-based chemotherapy (i.e., second-line SCLC subjects) or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed)tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4) who have progressed on SoC therapy and with no curative therapy options available. * Part 4b only: Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed) * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for participants with extracranial solid tumors or Response Assessment for Neuro-Oncology (RANO)for participants with primary high-grade CNS tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4). * Primary CNS tumors within 12 weeks from radiation therapy should have unequivocal progression as documented by either tumor recurrence predominantly outside of radiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy. * Participants with brain metastases from an extracranial solid tumor are eligible if the brain metastases as outlined in the protocol. * Fresh or archival tumor tissue available for submission, for retrospective SEZ6 expression analysis as outlined in the protocol. Exclusion Criteria: * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis. * History of idiopathic pulmonary fibrosis or organizing pneumonia. * Prior treatment with an antibody drug conjugate that consists of a Top1 inhibitor payload. * Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Heidelberg, Victoria, 3084, Australia
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Banner MD Anderson Cancer Ctr /ID# 260129
Gilbert, Arizona, 85234, United States
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Barbara Ann Karmanos Cancer In /ID# 261799
Detroit, Michigan, 48201, United States
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CHA Bundang Medical Center /ID# 248939
Seongnam, Gyeonggido, 13496, South Korea
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Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
Beijing, Beijing Municipality, 100021, China
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Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Berlin, 12203, Germany
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Chonnam National University Hwasun Hospital /ID# 248943
Hwasun-gun, Jeonranamdo, 58128, South Korea
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Chris O'Brien Lifehouse /ID# 259087
Camperdown, New South Wales, 2050, Australia
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City Of Hope Comprehensive Cancer Center /ID# 271295
Duarte, California, 91030, United States
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City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884
Irvine, California, 92618, United States
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Duke Cancer Center /ID# 246285
Durham, North Carolina, 27710, United States
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First Affiliated Hospital of China Medical University /ID# 270041
Shenyang, Liaoning, 110001, China
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Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
Monza, Monza E Brianza, 20052, Italy
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Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Fort Wayne, Indiana, 46804, United States
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Georgetown University Hospital /ID# 255352
Washington D.C., District of Columbia, 20007, United States
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Hadassah Medical Center-Hebrew University /ID# 255147
Jerusalem, 91120, Israel
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Henry Ford Hospital /ID# 246648
Detroit, Michigan, 48202, United States
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Hokkaido Cancer Center /ID# 261278
Sapporo, Hokkaido, 003-0804, Japan
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Hospital Clinico Universitario de Valencia /ID# 257290
Valencia, 46010, Spain
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Hospital HM Nou Delfos /ID# 264851
Barcelona, 08023, Spain
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Hospital Santa Creu i Sant Pau /ID# 257294
Barcelona, 08041, Spain
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Hospital Universitario 12 de Octubre /ID# 258658
Madrid, 28041, Spain
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Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Madrid, 28040, Spain
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Hospital Universitario HM Sanchinarro /ID# 258657
Madrid, 28050, Spain
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Hospital Universitario Ramon y Cajal /ID# 257291
Madrid, 28034, Spain
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Hospital Universitario Vall de Hebron /ID# 258659
Barcelona, 08035, Spain
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Hospital Universitario Virgen del Rocio /ID# 256940
Seville, 41013, Spain
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Institut Bergonie /ID# 258655
Bordeaux, Gironde, 33000, France
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Institut Gustave Roussy /ID# 260334
Villejuif, Val-de-Marne, 94805, France
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Institut Régional du Cancer Montpellier /ID# 265086
Montpellier, 34298, France
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Istituto Europeo Di Oncologia /ID# 256804
Milan, Milano, 20141, Italy
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Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
Munich, Bavaria, 80336, Germany
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Kyoto University Hospital /ID# 259419
Kyoto, Kyoto, 606-8507, Japan
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Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
New York, New York, 10065-6007, United States
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National Cancer Center /ID# 248938
Goyang-si, Gyeonggido, 10408, South Korea
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National Cancer Center Hospital /ID# 259418
Chuo-ku, Tokyo, 104-0045, Japan
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National Cancer Center Hospital East /ID# 259417
Kashiwa-shi, Chiba, 277-8577, Japan
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National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama, Ehime, 791-0280, Japan
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Northwest Medical Specialties - Tacoma /ID# 262801
Tacoma, Washington, 98405, United States
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Peter MacCallum Cancer Ctr /ID# 259197
Melbourne, Victoria, 3000, Australia
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Rambam Health Care Campus /ID# 255059
Haifa, 3109601, Israel
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START Midwest /ID# 251257
Grand Rapids, Michigan, 49546-7062, United States
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Samsung Medical Center /ID# 248936
Seoul, Seoul Teugbyeolsi, 06351, South Korea
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Seoul National University Hospital /ID# 248940
Seoul, Seoul Teugbyeolsi, 03080, South Korea
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Shanghai Chest Hospital /ID# 270036
Shanghai, Shanghai Municipality, 200030, China
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Shanghai East Hospital /ID# 268615
Shanghai, Shanghai Municipality, 200120, China
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Shanghai Pulmonary Hospital /Id# 270039
Shanghai, Shanghai Municipality, 200433, China
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Shizuoka Cancer Center /ID# 261277
Sunto-gun, Shizuoka, 411-8777, Japan
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South Texas Accelerated Research Therapeutics /ID# 248946
San Antonio, Texas, 78229, United States
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St. Lukes Hosp. of Kansas City /ID# 259958
Kansas City, Missouri, 64111, United States
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Tennessee Oncology, PLLC /ID# 246283
Nashville, Tennessee, 37203, United States
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The Cancer Institute Hospital Of JFCR /ID# 260132
Koto-ku, Tokyo, 135-8550, Japan
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The Chaim Sheba Medical Center /ID# 254915
Ramat Gan, Tel Aviv, 5265601, Israel
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The Kinghorn Cancer Centre /ID# 260874
Darlinghurst, New South Wales, 2010, Australia
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UH Cleveland Medical Center /ID# 246641
Cleveland, Ohio, 44106, United States
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Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
Wuhan, Hubei, 430022, China
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Univ Oklahoma HSC /ID# 250884
Oklahoma City, Oklahoma, 73117, United States
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Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414
Dresden, Saxony, 01307, Germany
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University of Chicago Medical Center /ID# 256334
Chicago, Illinois, 60637, United States
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University of Iowa Hospitals and Clinics /ID# 246638
Iowa City, Iowa, 52242, United States
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University of Texas MD Anderson Cancer Center /ID# 246287
Houston, Texas, 77030, United States
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University of Utah /ID# 246640
Salt Lake City, Utah, 84112-5500, United States
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Wakayama Medical University Hospital /ID# 260131
Wakayama, Wakayama, 641-8510, Japan
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Washington University-School of Medicine /ID# 246286
St Louis, Missouri, 63110, United States
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Yale New Haven Hospital /ID# 246647
New Haven, Connecticut, 06510, United States
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Yonsei University Health System Severance Hospital /ID# 248937
Seoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a trio of repurposed drugs shrink recurrent brain tumors?
- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors