NCT05599984Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 288 (actual)
- First submitted
- 28 Oct 2022
- Start date
- 5 Dec 2022
- Primary completion date
- Nov 2027
- Lead sponsor
- AbbVie
- Diseases
- Lung cancer
- NCT number
- NCT05599984
- EU CT number
- 2023-504598-18-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 288
- From 5 Dec 2022 to the primary completion date, Nov 2027
- 66 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
- 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.
Other illness
- History of idiopathic pulmonary fibrosis or organizing pneumonia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (66)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris O'Brien Lifehouse /ID# 259087 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| The Kinghorn Cancer Centre /ID# 260874 Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Austin Health and Ludwig Institute for Cancer Research /ID# 255174 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Peter MacCallum Cancer Ctr /ID# 259197 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shanghai Chest Hospital /ID# 270036 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai East Hospital /ID# 268615 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Pulmonary Hospital /Id# 270039 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| First Affiliated Hospital of China Medical University /ID# 270041 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414 Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Hospital Santa Creu i Sant Pau /ID# 257294 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Vall de Hebron /ID# 258659 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital HM Nou Delfos /ID# 264851 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Ramon y Cajal /ID# 257291 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario HM Sanchinarro /ID# 258657 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 257295 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre /ID# 258658 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio /ID# 256940 Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia /ID# 257290 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Institut Bergonie /ID# 258655 Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Institut Régional du Cancer Montpellier /ID# 265086 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Institut Gustave Roussy /ID# 260334 Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Rambam Health Care Campus /ID# 255059 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 255147 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 254915 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Istituto Europeo Di Oncologia /ID# 256804 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228 Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| National Cancer Center Hospital /ID# 259418 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| National Cancer Center Hospital East /ID# 259417 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| The Cancer Institute Hospital Of JFCR /ID# 260132 Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Kyoto University Hospital /ID# 259419 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center /ID# 261279 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Hokkaido Cancer Center /ID# 261278 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Shizuoka Cancer Center /ID# 261277 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| Wakayama Medical University Hospital /ID# 260131 Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| National Cancer Center /ID# 248938 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital /ID# 248943 Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Unknown status |
| CHA Bundang Medical Center /ID# 248939 Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Samsung Medical Center /ID# 248936 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 248940 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 248937 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| University of Chicago Medical Center /ID# 256334 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| UH Cleveland Medical Center /ID# 246641 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Henry Ford Hospital /ID# 246648 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Barbara Ann Karmanos Cancer In /ID# 261799 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City Of Hope Comprehensive Cancer Center /ID# 271295 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke Cancer Center /ID# 246285 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Banner MD Anderson Cancer Ctr /ID# 260129 Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| START Midwest /ID# 251257 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Texas MD Anderson Cancer Center /ID# 246287 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Hospitals and Clinics /ID# 246638 Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884 Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| St. Lukes Hosp. of Kansas City /ID# 259958 Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Tennessee Oncology, PLLC /ID# 246283 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital /ID# 246647 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Univ Oklahoma HSC /ID# 250884 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Utah /ID# 246640 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| South Texas Accelerated Research Therapeutics /ID# 248946 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Washington University-School of Medicine /ID# 246286 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Northwest Medical Specialties - Tacoma /ID# 262801 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Georgetown University Hospital /ID# 255352 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- SEZ6-targeting antibody-drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial.Nat Med · 2026 · PMID 42225988
This page is information, not medical advice. Discuss any trial with your doctor.