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
NCT ID: NCT05599984
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
288 participants
INTERVENTIONAL
2022-12-05
2026-06-30
Brief Summary
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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 350 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 3 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: ABBV-706 Monotherapy Dose Escalation
Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.
ABBV-706
Intravenous (IV) Infusion
Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 1 year treatment period..
ABBV-706
Intravenous (IV) Infusion
Part 3a: ABBV-706 + Budigalimab
Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.
ABBV-706
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Part 3b: ABBV-706 + Platinum Chemotherapy
Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.
ABBV-706
Intravenous (IV) Infusion
Cisplatin
Intravenous infusion
Carboplatin
Intravenous infusion
Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 1 year treatment period.
ABBV-706
Intravenous (IV) Infusion
Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 1 year treatment period.
ABBV-706
Intravenous (IV) Infusion
Interventions
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ABBV-706
Intravenous (IV) Infusion
Cisplatin
Intravenous infusion
Budigalimab
IV Infusion
Carboplatin
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: Participants with R/R SCLC following at least 1 prior platinum-containing chemotherapy or R/R poorly differentiated NECs, e.g., NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant Non-small cell lung cancer (NSCLC), atypical lung carcinoids, other high-grade poorly differentiated NECs.
* Part 3b only: Participants with R/R SCLC who have only progressed following a frontline regimen containing a platinum-based chemotherapy or R/R NECs, e.g., NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, other NECs.
* Part 4a only: Participants with R/R 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) who have progressed on SoC therapy and with no curative therapy options available.
* Part 4b only: Participants with R/R neuroendocrine tumors, including NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, and other high-grade poorly differentiated NECs, who have progressed on SoC therapy and with no curative therapy options available.
* 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 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Banner MD Anderson Cancer Ctr /ID# 260129
Gilbert, Arizona, United States
City Of Hope Comprehensive Cancer Center /ID# 271295
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884
Irvine, California, United States
Yale New Haven Hospital /ID# 246647
New Haven, Connecticut, United States
Georgetown University Hospital /ID# 255352
Washington D.C., District of Columbia, United States
University of Chicago Medical Center /ID# 256334
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 246638
Iowa City, Iowa, United States
Barbara Ann Karmanos Cancer In /ID# 261799
Detroit, Michigan, United States
Henry Ford Hospital /ID# 246648
Detroit, Michigan, United States
START Midwest /ID# 251257
Grand Rapids, Michigan, United States
St. Lukes Hosp. of Kansas City /ID# 259958
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 246286
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
New York, New York, United States
Duke Cancer Center /ID# 246285
Durham, North Carolina, United States
UH Cleveland Medical Center /ID# 246641
Cleveland, Ohio, United States
Univ Oklahoma HSC /ID# 250884
Oklahoma City, Oklahoma, United States
Tennessee Oncology, PLLC /ID# 246283
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center /ID# 246287
Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 248946
San Antonio, Texas, United States
University of Utah /ID# 246640
Salt Lake City, Utah, United States
Northwest Medical Specialties - Tacoma /ID# 262801
Tacoma, Washington, United States
Chris O'Brien Lifehouse /ID# 259087
Camperdown, New South Wales, Australia
The Kinghorn Cancer Centre /ID# 260874
Darlinghurst, New South Wales, Australia
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 259197
Melbourne, Victoria, Australia
Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
Beijing, Beijing Municipality, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
Wuhan, Hubei, China
First Affiliated Hospital of China Medical University /ID# 270041
Shenyang, Liaoning, China
Shanghai Chest Hospital /ID# 270036
Shanghai, Shanghai Municipality, China
Shanghai East Hospital /ID# 268615
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital /Id# 270039
Shanghai, Shanghai Municipality, China
Institut Bergonie /ID# 258655
Bordeaux, Gironde, France
Institut Gustave Roussy /ID# 260334
Villejuif, Val-de-Marne, France
Institut Régional du Cancer Montpellier /ID# 265086
Montpellier, , France
Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
Munich, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414
Dresden, Saxony, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Berlin, , Germany
The Chaim Sheba Medical Center /ID# 254915
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 255059
Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 255147
Jerusalem, , Israel
Istituto Europeo Di Oncologia /ID# 256804
Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
Monza, Monza E Brianza, Italy
National Cancer Center Hospital East /ID# 259417
Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama, Ehime, Japan
Hokkaido Cancer Center /ID# 261278
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 259419
Kyoto, Kyoto, Japan
Shizuoka Cancer Center /ID# 261277
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 259418
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 260132
Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 260131
Wakayama, Wakayama, Japan
National Cancer Center /ID# 248938
Goyang-si, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 248939
Seongnam, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 248943
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Hospital /ID# 248940
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 248936
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 248937
Seoul, , South Korea
Hospital HM Nou Delfos /ID# 264851
Barcelona, , Spain
Hospital Universitario Vall de Hebron /ID# 258659
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 257294
Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 257291
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 258658
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 258657
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 256940
Seville, , Spain
Hospital Clinico Universitario de Valencia /ID# 257290
Valencia, , Spain
Countries
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Related Links
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Other Identifiers
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M23-385
Identifier Type: -
Identifier Source: org_study_id
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