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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

Full criteria on ClinicalTrials.gov

Sites (66)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chris O'Brien Lifehouse /ID# 259087
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CamperdownAustraliaUnknown status
The Kinghorn Cancer Centre /ID# 260874
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DarlinghurstAustraliaUnknown status
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
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HeidelbergAustraliaUnknown status
Peter MacCallum Cancer Ctr /ID# 259197
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MelbourneAustraliaUnknown status
Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
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BeijingChinaUnknown status
Shanghai Chest Hospital /ID# 270036
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ShanghaiChinaUnknown status
Shanghai East Hospital /ID# 268615
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ShanghaiChinaUnknown status
Shanghai Pulmonary Hospital /Id# 270039
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ShanghaiChinaUnknown status
First Affiliated Hospital of China Medical University /ID# 270041
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ShenyangChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
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WuhanChinaUnknown status
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
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BerlinGermanyUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414
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DresdenGermanyUnknown status
Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
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MunichGermanyUnknown status
Hospital Santa Creu i Sant Pau /ID# 257294
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BarcelonaSpainUnknown status
Hospital Universitario Vall de Hebron /ID# 258659
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BarcelonaSpainUnknown status
Hospital HM Nou Delfos /ID# 264851
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BarcelonaSpainUnknown status
Hospital Universitario Ramon y Cajal /ID# 257291
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MadridSpainUnknown status
Hospital Universitario HM Sanchinarro /ID# 258657
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MadridSpainUnknown status
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre /ID# 258658
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MadridSpainUnknown status
Hospital Universitario Virgen del Rocio /ID# 256940
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SevilleSpainUnknown status
Hospital Clinico Universitario de Valencia /ID# 257290
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ValenciaSpainUnknown status
Institut Bergonie /ID# 258655
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BordeauxFranceUnknown status
Institut Régional du Cancer Montpellier /ID# 265086
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MontpellierFranceUnknown status
Institut Gustave Roussy /ID# 260334
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VillejuifFranceUnknown status
Rambam Health Care Campus /ID# 255059
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HaifaIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 255147
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JerusalemIsraelUnknown status
The Chaim Sheba Medical Center /ID# 254915
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Ramat GanIsraelUnknown status
Istituto Europeo Di Oncologia /ID# 256804
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MilanItalyUnknown status
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
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MonzaItalyUnknown status
National Cancer Center Hospital /ID# 259418
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Chuo-kuJapanUnknown status
National Cancer Center Hospital East /ID# 259417
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Kashiwa-shiJapanUnknown status
The Cancer Institute Hospital Of JFCR /ID# 260132
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Koto-kuJapanUnknown status
Kyoto University Hospital /ID# 259419
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KyotoJapanUnknown status
National Hospital Organization Shikoku Cancer Center /ID# 261279
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MatsuyamaJapanUnknown status
Hokkaido Cancer Center /ID# 261278
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SapporoJapanUnknown status
Shizuoka Cancer Center /ID# 261277
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Sunto-gunJapanUnknown status
Wakayama Medical University Hospital /ID# 260131
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WakayamaJapanUnknown status
National Cancer Center /ID# 248938
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital /ID# 248943
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Hwasun-gunSouth KoreaUnknown status
CHA Bundang Medical Center /ID# 248939
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SeongnamSouth KoreaUnknown status
Samsung Medical Center /ID# 248936
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 248940
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SeoulSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 248937
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SeoulSouth KoreaUnknown status
University of Chicago Medical Center /ID# 256334
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ChicagoUnited StatesUnknown status
UH Cleveland Medical Center /ID# 246641
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ClevelandUnited StatesUnknown status
Henry Ford Hospital /ID# 246648
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DetroitUnited StatesUnknown status
Barbara Ann Karmanos Cancer In /ID# 261799
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DetroitUnited StatesUnknown status
City Of Hope Comprehensive Cancer Center /ID# 271295
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DuarteUnited StatesUnknown status
Duke Cancer Center /ID# 246285
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DurhamUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
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Fort WayneUnited StatesUnknown status
Banner MD Anderson Cancer Ctr /ID# 260129
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GilbertUnited StatesUnknown status
START Midwest /ID# 251257
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Grand RapidsUnited StatesUnknown status
University of Texas MD Anderson Cancer Center /ID# 246287
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HoustonUnited StatesUnknown status
University of Iowa Hospitals and Clinics /ID# 246638
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Iowa CityUnited StatesUnknown status
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884
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IrvineUnited StatesUnknown status
St. Lukes Hosp. of Kansas City /ID# 259958
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Kansas CityUnited StatesUnknown status
Tennessee Oncology, PLLC /ID# 246283
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NashvilleUnited StatesUnknown status
Yale New Haven Hospital /ID# 246647
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New HavenUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
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New YorkUnited StatesUnknown status
Univ Oklahoma HSC /ID# 250884
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Oklahoma CityUnited StatesUnknown status
University of Utah /ID# 246640
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Salt Lake CityUnited StatesUnknown status
South Texas Accelerated Research Therapeutics /ID# 248946
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San AntonioUnited StatesUnknown status
Washington University-School of Medicine /ID# 246286
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St LouisUnited StatesUnknown status
Northwest Medical Specialties - Tacoma /ID# 262801
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TacomaUnited StatesUnknown status
Georgetown University Hospital /ID# 255352
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Washington D.C.United StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.