Trial Title:
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
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Carboplatin
Conditions: Keywords:
Advanced Solid Tumors
Small Cell Lung Cancer
Central Nervous System Tumors
ABBV-706
ABBV-181
Budigalimab
Platinum Chemotherapy Combination
Carboplatin
Cisplatin
Neuroendocrine Carcinomas
Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-706
Description:
Intravenous (IV) Infusion
Arm group label:
Part 1: ABBV-706 Monotherapy Dose Escalation
Arm group label:
Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
Arm group label:
Part 3a: ABBV-706 + Budigalimab
Arm group label:
Part 3b: ABBV-706 + Platinum Chemotherapy
Arm group label:
Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
Arm group label:
Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Intravenous infusion
Arm group label:
Part 3b: ABBV-706 + Platinum Chemotherapy
Intervention type:
Drug
Intervention name:
Budigalimab
Description:
IV Infusion
Arm group label:
Part 3a: ABBV-706 + Budigalimab
Other name:
ABBV-181
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Intravenous infusion
Arm group label:
Part 3b: ABBV-706 + Platinum Chemotherapy
Summary:
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 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.
Criteria for eligibility:
Criteria:
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 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 interstitial lung disease (ILD) or pneumonitis that required treatment
with 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 inhibitor
payload.
- Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Ctr /ID# 260129
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
City Of Hope Comprehensive Cancer Center /ID# 271295
Address:
City:
Duarte
Zip:
91030
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center /ID# 259884
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale New Haven Hospital /ID# 246647
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown University Hospital /ID# 255352
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago /ID# 256334
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Iowa Hospitals and Clinics /ID# 246638
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
Barbara Ann Karmanos Cancer In /ID# 261799
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital /ID# 246648
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest /ID# 251257
Address:
City:
Grand Rapids
Zip:
49546-7062
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Luke's Hosp. of Kansas City /ID# 259958
Address:
City:
Kansas City
Zip:
64111
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University-School of Medicine /ID# 246286
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Center /ID# 246285
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
UH Cleveland Medical Center /ID# 246641
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ Oklahoma HSC /ID# 250884
Address:
City:
Oklahoma City
Zip:
73117
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology, PLLC /ID# 246283
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center /ID# 246287
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics /ID# 248946
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Utah /ID# 246640
Address:
City:
Salt Lake City
Zip:
84112-5500
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties - Tacoma /ID# 262801
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris O'Brien Lifehouse /ID# 259087
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Kinghorn Cancer Centre /ID# 260874
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health and Ludwig Institute for Cancer Research /ID# 255174
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Ctr /ID# 259197
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy /ID# 260334
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Régional du Cancer Montpellier /ID# 265086
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Facility:
Name:
Klinikum der Universität München - Campus Innenstadt /ID# 259412
Address:
City:
Munich
Zip:
80336
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Recruiting
Facility:
Name:
Technische Universitat Dresden /ID# 259414
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus /ID# 255059
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 254915
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 255147
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia /ID# 256804
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori /ID# 258228
Address:
City:
Monza
Zip:
20052
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 259417
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shikoku Cancer Center /ID# 261279
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido Cancer Center /ID# 261278
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital /ID# 259419
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center /ID# 261277
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 259418
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital Of JFCR /ID# 260132
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Wakayama Medical University Hospital /ID# 260131
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center /ID# 248938
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
CHA Bundang Medical Center /ID# 248939
Address:
City:
Seongnam
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital /ID# 248943
Address:
City:
Hwasun-gun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital /ID# 248940
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center /ID# 248936
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Yonsei University Health System Severance Hospital /ID# 248937
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital HM Nou Delfos /ID# 264851
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron /ID# 258659
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Santa Creu i Sant Pau /ID# 257294
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal /ID# 257291
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz /ID# 257295
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre /ID# 258658
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario HM Sanchinarro /ID# 258657
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio /ID# 256940
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia /ID# 257290
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
December 5, 2022
Completion date:
May 17, 2027
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05599984
https://www.abbvieclinicaltrials.com/study/?id=M24-108
