Phase
Condition
Small Cell Lung Cancer
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
AustraliaSite Not Available
The Kinghorn Cancer Centre /ID# 260874
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Chris O'Brien Lifehouse /ID# 259087
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
The Kinghorn Cancer Centre /ID# 260874
Darlinghurst 2169378, New South Wales 2155400 2010
AustraliaSite Not Available
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Heidelberg, Victoria 3084
AustraliaSite Not Available
Peter MacCallum Cancer Ctr /ID# 259197
Melbourne, Victoria 3000
AustraliaSite Not Available
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Heidelberg 2163654, Victoria 2145234 3084
AustraliaSite Not Available
Peter MacCallum Cancer Ctr /ID# 259197
Melbourne 2158177, Victoria 2145234 3000
AustraliaSite Not Available
Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
Beijing, Beijing 100021
ChinaSite Not Available
Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044
Beijing 1816670, Beijing Municipality 2038349 100021
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
Wuhan, Hubei 430022
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038
Wuhan 1791247, Hubei 1806949 430022
ChinaSite Not Available
The first hospital of China medical University /ID# 270041
Shenyang, Liaoning 110001
ChinaSite Not Available
First Affiliated Hospital of China Medical University /ID# 270041
Shenyang 2034937, Liaoning 2036115 110001
ChinaSite Not Available
The first hospital of China medical University /ID# 270041
Shenyang 2034937, Liaoning 2036115 110001
ChinaActive - Recruiting
Shanghai Chest Hospital /ID# 270036
Shanghai, Shanghai 200030
ChinaActive - Recruiting
Shanghai East Hospital /ID# 268615
Shanghai, Shanghai 200120
ChinaActive - Recruiting
Shanghai Pulmonary Hospital /Id# 270039
Shanghai, Shanghai 200433
ChinaSite Not Available
Shanghai Chest Hospital /ID# 270036
Shanghai 1796236, Shanghai Municipality 1796231 200030
ChinaSite Not Available
Shanghai East Hospital /ID# 268615
Shanghai 1796236, Shanghai Municipality 1796231 200120
ChinaSite Not Available
Shanghai Pulmonary Hospital /Id# 270039
Shanghai 1796236, Shanghai Municipality 1796231 200433
ChinaSite Not Available
Institut Bergonie /ID# 258655
Bordeaux, Gironde 33000
FranceSite Not Available
Institut Bergonie /ID# 258655
Bordeaux 3031582, Gironde 33000
FranceSite Not Available
Institut Gustave Roussy /ID# 260334
Villejuif 2968705, Val-de-Marne 94805
FranceSite Not Available
Institut Gustave Roussy /ID# 260334
Villejuif Cedex, Val-de-Marne 94805
FranceSite Not Available
Institut Régional du Cancer Montpellier /ID# 265086
Montpellier, 34298
FranceSite Not Available
Institut Régional du Cancer Montpellier /ID# 265086
Montpellier 2992166, 34298
FranceSite Not Available
Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
Munich 2867714, Bavaria 2951839 80336
GermanySite Not Available
Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412
Munich, Bayern 80336
GermanySite Not Available
Klinikum der Universität München - Campus Innenstadt /ID# 259412
Munich, Bayern 80336
GermanyActive - Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414
Dresden, Sachsen 01307
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414
Dresden 2935022, Saxony 2842566 01307
GermanySite Not Available
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Berlin, 12203
GermanySite Not Available
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Berlin 2950159, 12203
GermanySite Not Available
Technische Universitat Dresden /ID# 259414
Dresden, 01307
GermanyActive - Recruiting
Rambam Health Care Campus /ID# 255059
Haifa, H_efa 3109601
IsraelSite Not Available
The Chaim Sheba Medical Center /ID# 254915
Ramat Gan 293788, Tel Aviv 293396 5265601
IsraelSite Not Available
The Chaim Sheba Medical Center /ID# 254915
Ramat Gan, Tel-Aviv 5265601
IsraelSite Not Available
Hadassah Medical Center /ID# 255147
Jerusalem, Yerushalayim 9112001
IsraelActive - Recruiting
Rambam Health Care Campus /ID# 255059
Haifa 294801, 3109601
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 255147
Jerusalem, 91120
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 255147
Jerusalem 281184, 91120
IsraelSite Not Available
IEO -Istituto Europeo di Oncologia /ID# 256804
Milan, Milano 20141
ItalyActive - Recruiting
Istituto Europeo di Oncologia /ID# 256804
Milan, Milano 20141
ItalySite Not Available
Istituto Europeo Di Oncologia /ID# 256804
Milan 3173435, Milano 20141
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
Monza, Monza E Brianza 20052
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori /ID# 258228
Monza, Monza E Brianza 20052
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228
Monza 3172629, Monza E Brianza 20052
ItalySite Not Available
National Cancer Center Hospital East /ID# 259417
Kashiwa-shi, Chiba 2113014 277-8577
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama, Ehime 791-0280
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama-shi, Ehime 791-0280
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center /ID# 261279
Matsuyama 1926099, Ehime 1864226 791-0280
JapanSite Not Available
Hokkaido Cancer Center /ID# 261278
Sapporo-shi, Hokkaido 003-0804
JapanSite Not Available
Hokkaido Cancer Center /ID# 261278
Sapporo 2128295, Hokkaido 2130037 003-0804
JapanSite Not Available
Kyoto University Hospital /ID# 259419
Kyoto-shi, Kyoto 606-8507
JapanSite Not Available
Kyoto University Hospital /ID# 259419
Kyoto 1857910, Kyoto 1857907 606-8507
JapanSite Not Available
Shizuoka Cancer Center /ID# 261277
Sunto-gun, Shizuoka 1851715 411-8777
JapanSite Not Available
The Cancer Institute Hospital Of JFCR /ID# 260132
Koto, Tokyo 135-8550
JapanSite Not Available
National Cancer Center Hospital /ID# 259418
Chuo-ku, Tokyo 1850144 104-0045
JapanSite Not Available
The Cancer Institute Hospital Of JFCR /ID# 260132
Koto-ku, Tokyo 1850144 135-8550
JapanSite Not Available
Wakayama Medical University Hospital /ID# 260131
Wakayama-shi, Wakayama 641-8510
JapanSite Not Available
Wakayama Medical University Hospital /ID# 260131
Wakayama 1926004, Wakayama 1848938 641-8510
JapanSite Not Available
National Cancer Center /ID# 248938
Goyang, Gyeonggido 10408
Korea, Republic ofSite Not Available
National Cancer Center /ID# 248938
Goyang-si, Gyeonggido 10408
Korea, Republic ofSite Not Available
CHA Bundang Medical Center /ID# 248939
Seongnam, Gyeonggido 13496
Korea, Republic ofSite Not Available
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 ofSite Not Available
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
National Cancer Center /ID# 248938
Goyang-si 1842485, Gyeonggido 10408
South KoreaSite Not Available
CHA Bundang Medical Center /ID# 248939
Seongnam 6876792, Gyeonggido 13496
South KoreaSite Not Available
Chonnam National University Hwasun Hospital /ID# 248943
Hwasun-gun, Jeonranamdo 58128
South KoreaSite Not Available
Samsung Medical Center /ID# 248936
Seoul 1835848, Seoul Teugbyeolsi 06351
South KoreaSite Not Available
Seoul National University Hospital /ID# 248940
Seoul 1835848, Seoul Teugbyeolsi 03080
South KoreaSite Not Available
Yonsei University Health System Severance Hospital /ID# 248937
Seoul 1835848, 03722
South KoreaSite Not Available
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 Vall de Hebron /ID# 258659
Barcelona, 08035
SpainSite Not Available
Hospital HM Nou Delfos /ID# 264851
Barcelona 3128760, 08023
SpainSite Not Available
Hospital Santa Creu i Sant Pau /ID# 257294
Barcelona 3128760, 08041
SpainSite Not Available
Hospital Universitario Vall de Hebron /ID# 258659
Barcelona 3128760, 08035
SpainSite Not Available
Hospital Universitario 12 de Octubre /ID# 258658
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Madrid, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro /ID# 258657
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal /ID# 257291
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 258658
Madrid 3117735, 28041
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Madrid 3117735, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro /ID# 258657
Madrid 3117735, 28050
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 257291
Madrid 3117735, 28034
SpainSite Not Available
Duplicate_Hospital Universitario Virgen del Rocio /ID# 256940
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen del Rocio /ID# 256940
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio /ID# 256940
Seville 2510911, 41013
SpainSite Not Available
Hospital Clinico Universitario de Valencia /ID# 257290
Valencia, 46010
SpainSite Not Available
Hospital Clinico Universitario de Valencia /ID# 257290
Valencia 2509954, 46010
SpainSite Not Available
Banner MD Anderson Cancer Ctr /ID# 260129
Gilbert, Arizona 85234
United StatesSite Not Available
Banner MD Anderson Cancer Ctr /ID# 260129
Gilbert 5295903, Arizona 5551752 85234
United StatesSite Not Available
City Of Hope Comprehensive Cancer Center /ID# 271295
Duarte, California 91030
United StatesSite Not Available
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 StatesSite Not Available
City of Hope Orange County Lennar Foundation Cancer Center /ID# 259884
Irvine, California 92618
United StatesActive - Recruiting
City Of Hope Comprehensive Cancer Center /ID# 271295
Duarte 5344147, California 5332921 91030
United StatesSite Not Available
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884
Irvine 5359777, California 5332921 92618
United StatesSite Not Available
Yale New Haven Hospital /ID# 246647
New Haven, Connecticut 06510
United StatesSite Not Available
Yale School of Medicine /ID# 246647
New Haven, Connecticut 06519
United StatesActive - Recruiting
Yale New Haven Hospital /ID# 246647
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Georgetown University Hospital /ID# 255352
Washington, District of Columbia 20007
United StatesSite Not Available
Georgetown University Hospital /ID# 255352
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
University of Chicago /ID# 256334
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago /ID# 256334
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
University of Chicago Medical Center /ID# 256334
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Fort Wayne, Indiana 46804
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Fort Wayne 4920423, Indiana 4921868 46804
United StatesSite Not Available
University of Iowa Hospitals and Clinics /ID# 246638
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics /ID# 246638
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Barbara Ann Karmanos Cancer In /ID# 261799
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Hospital /ID# 246648
Detroit, Michigan 48202
United StatesActive - Recruiting
START Midwest /ID# 251257
Grand Rapids, Michigan 49546-7062
United StatesSite Not Available
Barbara Ann Karmanos Cancer In /ID# 261799
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Henry Ford Hospital /ID# 246648
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
START Midwest /ID# 251257
Grand Rapids 4994358, Michigan 5001836 49546-7062
United StatesSite Not Available
St. Luke's Hosp. of Kansas City /ID# 259958
Kansas City, Missouri 64111
United StatesActive - Recruiting
St. Lukes Hosp. of Kansas City /ID# 259958
Kansas City, Missouri 64111
United StatesSite Not Available
Washington University-School of Medicine /ID# 246286
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University-School of Medicine /ID# 246286
St. Louis, Missouri 63110
United StatesSite Not Available
St. Lukes Hosp. of Kansas City /ID# 259958
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Washington University-School of Medicine /ID# 246286
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
New York, New York 10065-6007
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
New York 5128581, New York 5128638 10065-6007
United StatesSite Not Available
Duke Cancer Center /ID# 246285
Durham, North Carolina 27710
United StatesSite Not Available
Duke Cancer Center /ID# 246285
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
UH Cleveland Medical Center /ID# 246641
Cleveland, Ohio 44106
United StatesSite Not Available
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
UH Cleveland Medical Center /ID# 246641
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Univ Oklahoma HSC /ID# 250884
Oklahoma City, Oklahoma 73117
United StatesSite Not Available
Univ Oklahoma HSC /ID# 250884
Oklahoma City 4544349, Oklahoma 4544379 73117
United StatesSite Not Available
Tennessee Oncology, PLLC /ID# 246283
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology, PLLC /ID# 246283
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
University of Texas MD Anderson Cancer Center /ID# 246287
Houston, Texas 77030
United StatesSite Not Available
South Texas Accelerated Research Therapeutics /ID# 248946
San Antonio, Texas 78229
United StatesSite Not Available
University of Texas MD Anderson Cancer Center /ID# 246287
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
South Texas Accelerated Research Therapeutics /ID# 248946
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
University of Utah /ID# 246640
Salt Lake City, Utah 84112-5500
United StatesSite Not Available
University of Utah /ID# 246640
Salt Lake City 5780993, Utah 5549030 84112-5500
United StatesSite Not Available
Northwest Medical Specialties - Tacoma /ID# 262801
Tacoma, Washington 98405
United StatesSite Not Available
Northwest Medical Specialties - Tacoma /ID# 262801
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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