Phase
Condition
Neoplasms
Treatment
Cisplatin
Carboplatin
ABBV-706
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofstudy 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% asmeasured by echocardiogram or multigated acquisition (MUGA) scan at Screening.
Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6expression including small cell lung cancer (SCLC), high-grade central nervoussystem (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 differentiatedgastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cellneuroendocrine carcinoma (LCNEC)s, SCLC transformed from epidermal growth factorreceptor (EGFR) mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids,and other high-grade poorly differentiated NECs, who have progressed on or afterstandard of care (SoC) therapy and with no curative therapy available. For SCLC,participants must have histologically or cytologically confirmed SCLC that isrelapsed or refractory following at least 1 prior platinum-containing chemotherapy.
Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed orrefractory (R/R) following at least 1 prior platinum-containing chemotherapy andwith no curative therapy available. For the purposes of this study, a line oftherapy is defined as >= 1 complete cycle of either a single agent or combination ofdrugs, including any planned sequential therapy of various regimens.
Part 3a only: Participants with R/R SCLC following at least 1 priorplatinum-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 afrontline 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 nocurative 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 otherhigh-grade poorly differentiated NECs, who have progressed on SoC therapy and withno 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 forNeuro-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 unequivocalprogression as documented by either tumor recurrence predominantly outside ofradiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy.
Participants with brain metastases from an extracranial solid tumor are eligible ifthe brain metastases as outlined in the protocol.
Fresh or archival tumor tissue available for submission, for retrospective SEZ6expression analysis as outlined in the protocol.
Exclusion
Exclusion Criteria:
History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith 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 inhibitorpayload.
Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.
Study Design
Connect with a study center
Chris O'Brien Lifehouse /ID# 259087
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
The Kinghorn Cancer Centre /ID# 260874
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Peter MacCallum Cancer Ctr /ID# 259197
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
Beijing, Beijing 100021
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
Wuhan, Hubei 430022
ChinaActive - Recruiting
The first hospital of China medical University /ID# 270041
Shenyang, Liaoning 110001
ChinaActive - Recruiting
Shanghai East Hospital /ID# 268615
Shanghai, Shanghai 200120
ChinaActive - Recruiting
Institut Bergonie /ID# 258655
Bordeaux, Gironde 33000
FranceActive - Recruiting
Institut Gustave Roussy /ID# 260334
Villejuif Cedex, Val-de-Marne 94805
FranceActive - Recruiting
Institut Régional du Cancer Montpellier /ID# 265086
Montpellier, 34298
FranceActive - Recruiting
Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
Munich, Bayern 80336
GermanyActive - Recruiting
Klinikum der Universität München - Campus Innenstadt /ID# 259412
Munich, Bayern 80336
GermanyActive - Recruiting
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Berlin, 12203
GermanyActive - Recruiting
Technische Universitat Dresden /ID# 259414
Dresden, 01307
GermanyActive - Recruiting
Rambam Health Care Campus /ID# 255059
Haifa, H_efa 3109601
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 254915
Ramat Gan, Tel-Aviv 5265601
IsraelActive - Recruiting
Hadassah Medical Center /ID# 255147
Jerusalem, Yerushalayim 9112001
IsraelActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 255147
Jerusalem, 91120
IsraelActive - Recruiting
IEO -Istituto Europeo di Oncologia /ID# 256804
Milan, Milano 20141
ItalyActive - Recruiting
Istituto Europeo Di Oncologia /ID# 256804
Milan, Milano 20141
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
Monza, Monza E Brianza 20052
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori /ID# 258228
Monza, Monza E Brianza 20052
ItalyActive - Recruiting
National Cancer Center Hospital East /ID# 259417
Kashiwa-shi, Chiba 277-8577
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama, Ehime 791-0280
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama-shi, Ehime 791-0280
JapanSite Not Available
Hokkaido Cancer Center /ID# 261278
Sapporo-shi, Hokkaido 003-0804
JapanActive - Recruiting
Kyoto University Hospital /ID# 259419
Kyoto-shi, Kyoto 606-8507
JapanActive - Recruiting
Shizuoka Cancer Center /ID# 261277
Sunto-gun, Shizuoka 411-8777
JapanActive - Recruiting
National Cancer Center Hospital /ID# 259418
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital Of JFCR /ID# 260132
Koto, Tokyo 135-8550
JapanSite Not Available
The Cancer Institute Hospital Of JFCR /ID# 260132
Koto-ku, Tokyo 135-8550
JapanActive - Recruiting
Wakayama Medical University Hospital /ID# 260131
Wakayama-shi, Wakayama 641-8510
JapanActive - Recruiting
National Cancer Center /ID# 248938
Goyang, Gyeonggido 10408
Korea, Republic ofSite Not Available
National Cancer Center /ID# 248938
Goyang-si, Gyeonggido 10408
Korea, Republic ofActive - Recruiting
CHA Bundang Medical Center /ID# 248939
Seongnam, Gyeonggido 13496
Korea, Republic ofActive - Recruiting
CHA University Bundang Medical Center /ID# 248939
Seongnam si, Gyeonggido 13496
Korea, Republic ofSite Not Available
CHA Bundang Medical Center /ID# 248939
성남시, Gyeonggido 13496
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital /ID# 248943
Hwasun-gun, Jeonranamdo 58128
Korea, Republic ofActive - Recruiting
Samsung Medical Center /ID# 248936
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital /ID# 248940
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital /ID# 248943
Jeonnam, 58128
Korea, Republic ofSite Not Available
Yonsei University Health System Severance Hospital /ID# 248937
Seoul, 03722
Korea, Republic ofActive - Recruiting
Hospital HM Nou Delfos /ID# 264851
Barcelona, 08023
SpainActive - Recruiting
Hospital Santa Creu i Sant Pau /ID# 257294
Barcelona, 08041
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron /ID# 258659
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 258658
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro /ID# 258657
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal /ID# 257291
Madrid, 28034
SpainActive - Recruiting
Duplicate_Hospital Universitario Virgen del Rocio /ID# 256940
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio /ID# 256940
Sevilla, 41013
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia /ID# 257290
Valencia, 46010
SpainActive - Recruiting
Banner MD Anderson Cancer Ctr /ID# 260129
Gilbert, Arizona 85234
United StatesActive - Recruiting
City Of Hope Comprehensive Cancer Center /ID# 271295
Duarte, California 91030
United StatesActive - Recruiting
City of Hope /ID# 259884
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Orange County Lennar Foundation Cancer Center /ID# 259884
Irvine, California 92618
United StatesActive - Recruiting
Yale New Haven Hospital /ID# 246647
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale School of Medicine /ID# 246647
New Haven, Connecticut 06519
United StatesActive - Recruiting
Georgetown University Hospital /ID# 255352
Washington, District of Columbia 20007
United StatesActive - Recruiting
University of Chicago /ID# 256334
Chicago, Illinois 60637
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics /ID# 246638
Iowa City, Iowa 52242
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer In /ID# 261799
Detroit, Michigan 48201
United StatesActive - Recruiting
Henry Ford Hospital /ID# 246648
Detroit, Michigan 48202
United StatesActive - Recruiting
START Midwest /ID# 251257
Grand Rapids, Michigan 49546-7062
United StatesActive - Recruiting
St. Luke's Hosp. of Kansas City /ID# 259958
Kansas City, Missouri 64111
United StatesActive - Recruiting
Washington University-School of Medicine /ID# 246286
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
New York, New York 10065-6007
United StatesActive - Recruiting
Duke Cancer Center /ID# 246285
Durham, North Carolina 27710
United StatesActive - Recruiting
UH Cleveland Medical Center /ID# 246641
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center Seidman Cancer Center /ID# 246641
Cleveland, Ohio 44106
United StatesActive - Recruiting
Univ Oklahoma HSC /ID# 250884
Oklahoma City, Oklahoma 73117
United StatesActive - Recruiting
Tennessee Oncology, PLLC /ID# 246283
Nashville, Tennessee 37203
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center /ID# 246287
Houston, Texas 77030
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics /ID# 248946
San Antonio, Texas 78229
United StatesActive - Recruiting
University of Utah /ID# 246640
Salt Lake City, Utah 84112-5500
United StatesActive - Recruiting
Northwest Medical Specialties - Tacoma /ID# 262801
Tacoma, Washington 98405
United StatesActive - Recruiting
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