Phase
Condition
Neoplasm Metastasis
Treatment
ABBV-CLS-484
Programmed Cell Death-1 (PD-1) Inhibitor
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must weigh at least 35 kilograms (kg).
An Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Life expectancy of >= 12 weeks.
Laboratory values meeting protocol criteria.
QT interval corrected for heart rate < 470 msec (using Fridericia's correction), andno clinically significant electrocardiographic findings.
Measurable disease defined by RECIST 1.1 criteria.
For Monotherapy and Combination Dose Escalation:
- Participants with histologically or cytologically proven metastatic or locallyadvanced tumors, for which no effective standard therapy exists, or where standardtherapy has failed. Participants must have received at least 1 prior systemicanticancer therapy for the indication being considered.
For Monotherapy Dose Expansion only:
Participants must have received at least 1 prior line containing PD-1/PD-L1 targetedtherapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stabledisease (for greater than 6 months); AND
Must have been previously treated with 1 or more prior lines of therapy in thelocally advanced or metastatic setting with the following tumor types:
Relapsed/refractory HNSCC
Relapsed/refractory NSCLC
Advanced ccRCC
For PD-1 Targeting Agent Combination Dose Expansion only:
For the following tumor types, subject must have received at least 1 prior linecontaining PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (anyduration) or stable disease (for greater than 6 months):
Relapsed HNSCC
Relapsed NSCLC
Relapsed Advanced ccRCC
For the following tumor types, subject must have received at least 1 prior linecontaining PD-1/PD-L1 targeted therapy and have had disease progression withPD-1/PD-L1 targeted therapy:
Locally Advanced or metastatic MSI-H tumors
For VEGFR TKI Combination Dose Expansion only:
Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
Participants no recent history of hemorrhage, including hemoptysis, hematemesis, ormelena
Participants with poorly controlled hypertension are excluded.
Exclusion
Exclusion Criteria:
Untreated brain or meningeal metastases (i.e., subjects with history of metastasesare eligible provided they do not require ongoing steroid treatment and have shownclinical and radiographic stability for at least 28 days after definitive therapy)
Unresolved Grade 2 or higher toxicities related to previous anticancer therapyexcept alopecia.
Unresolved Grade 2 or higher peripheral neuropathy.
History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)infection.
Recent history (within 6 months) of congestive heart failure (defined as New YorkHeart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis,or clinically significant pericardial effusion or arrythmia.
Recent history (within 6 months) of Childs-Pugh B or C classification of liverdisease.
History of clinically significant medical and/or psychiatric conditions or any otherreason that, in the opinion of the investigator, would interfere with the subject'sparticipation in this study or would make the subject an unsuitable candidate toreceive study drug.
History of uncontrolled, clinically significant endocrinopathy.
Known gastrointestinal disorders making absorption of oral medications problematic;subject must be able to swallow capsules.
If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past,excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity,hypersensitivity to administered drug or drug related toxicity requiringdiscontinuation.
Active autoimmune disease requiring systemic treatment in past 2-years (exceptionsfor endocrinopathies, vitiligo or atopic conditions).
History of solid organ transplant or allogeneic stem cell transplant.
History of other malignancy, with the following exceptions:advanced tumors, for which no effective standard therapy exists, or where standard
therapy has failed. Participants must have received at least 1 prior systemic
anticancer therapy for the indication being considered.
 
 For Monotherapy Dose Expansion only:
 
Participants must have received at least 1 prior line containing PD-1/PD-L1 targeted
therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable
disease (for greater than 6 months); AND
 
Must have been previously treated with 1 or more prior lines of therapy in the
locally advanced or metastatic setting with the following tumor types:
 
Relapsed/refractory HNSCC
 
Relapsed/refractory NSCLC
 
Advanced ccRCC
 
 For PD-1 Targeting Agent Combination Dose Expansion only:
 
For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any
duration) or stable disease (for greater than 6 months):
 
Relapsed HNSCC
 
Relapsed NSCLC
 
Relapsed Advanced ccRCC
 
For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy and have had disease progression with
PD-1/PD-L1 targeted therapy:
 
Locally Advanced or metastatic MSI-H tumors
 
 For VEGFR TKI Combination Dose Expansion only:
 
Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
 
Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or
melena
 
Participants with poorly controlled hypertension are excluded.
 
 Exclusion Criteria:
 
Untreated brain or meningeal metastases (i.e., subjects with history of metastases
are eligible provided they do not require ongoing steroid treatment and have shown
clinical and radiographic stability for at least 28 days after definitive therapy)
 
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy
except alopecia.
 
Unresolved Grade 2 or higher peripheral neuropathy.
 
History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
infection.
 
Recent history (within 6 months) of congestive heart failure (defined as New York
Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis,
or clinically significant pericardial effusion or arrythmia.
 
Recent history (within 6 months) of Childs-Pugh B or C classification of liver
disease.
 
History of clinically significant medical and/or psychiatric conditions or any other
reason that, in the opinion of the investigator, would interfere with the subject's
participation in this study or would make the subject an unsuitable candidate to
receive study drug.
 
History of uncontrolled, clinically significant endocrinopathy.
 
Known gastrointestinal disorders making absorption of oral medications problematic;
subject must be able to swallow capsules.
 
If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past,
excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity,
hypersensitivity to administered drug or drug related toxicity requiring
discontinuation.
 
Active autoimmune disease requiring systemic treatment in past 2-years (exceptions
for endocrinopathies, vitiligo or atopic conditions).
 
History of solid organ transplant or allogeneic stem cell transplant.
 
History of other malignancy, with the following exceptions:
No known active disease present within >= 3 years before first dose of studytreatment and felt to be at low recurrence by investigator.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidenceof disease.
Adequately treated carcinoma in situ without evidence of disease.
History of interstitial lung disease or pneumonitis.
Major surgery <= 28 days prior to first dose of study drug
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionper local testing practices.
Study Design
Connect with a study center
Institut Paoli-Calmettes /ID# 260956
Marseille, Bouches-du-Rhone 13009
FranceActive - Recruiting
Hospital Foch
Suresnes, Ile-de-France 92150
FranceSite Not Available
IUCT Oncopole /ID# 252673
Toulouse Cedex 9, Occitanie 31059
FranceActive - Recruiting
Centre Antoine-Lacassagne /ID# 252606
Nice, Provence-Alpes-Cote-d Azur 06189
FranceActive - Recruiting
Centre Antoine Lacassagne - Nice
Nice, 06189
FranceActive - Recruiting
Hopital Foch /ID# 252607
Suresnes CEDEX, 92151
FranceActive - Recruiting
IUCT Oncopole
Toulouse, 31059
FranceSite Not Available
Rabin Medical Center /ID# 263631
Petah Tikva, HaMerkaz 4941492
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, Hamerkaz 4941492
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 226756
Ramat Gan, Tel-Aviv 5265601
IsraelActive - Recruiting
Hadassah Medical Center /ID# 252366
Jerusalem, Yerushalayim 91120
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 91120
IsraelActive - Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5262100
IsraelActive - Recruiting
Wakayama Medical University Hospital
Wakayama, Kimiidera 641-8510
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
National Cancer Center Hospital /ID# 225884
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
Wakayama Medical University Hospital /ID# 252988
Wakayama-shi, Wakayama 641-8510
JapanActive - Recruiting
Samsung Medical Center /ID# 260664
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital /ID# 254635
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Yonsei University Health System Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
Yonsei University Health System Severance Hospital /ID# 260665
Seoul, 03722
Korea, Republic ofActive - Recruiting
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
L'Hospitalet de Llobregat, Barcelona 08907
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 257374
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro /ID# 228034
Madrid, 28050
SpainActive - Recruiting
University of Arizona Cancer Center - Tucson
Tucson, Arizona 85719
United StatesActive - Recruiting
University of Arizona Cancer Center - Tucson /ID# 262698
Tucson, Arizona 85724
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06519
United StatesActive - Recruiting
Yale University School of Medicine /ID# 225707
New Haven, Connecticut 06510
United StatesActive - Recruiting
Johns Hopkins Hospital /ID# 254056
Baltimore, Maryland 21287
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215-5400
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center /ID# 252009
Boston, Massachusetts 02215-5400
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Dana-Farber Cancer Institute /ID# 249642
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan 48109-5000
United StatesActive - Recruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
NYU Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United StatesActive - Recruiting
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869
New York, New York 10016
United StatesActive - Recruiting
Duke Cancer Center /ID# 251975
Durham, North Carolina 27710
United StatesActive - Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Carolina BioOncology Institute /ID# 225704
Huntersville, North Carolina 28078
United StatesSite Not Available
Perelman Center for Advanced Medicine /ID# 250188
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
UPMC Hillman Cancer Ctr /ID# 225706
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island 02903
United StatesActive - Recruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705
Providence, Rhode Island 02903-4923
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center /ID# 251974
Dallas, Texas 75390-7208
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center /ID# 252004
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology /ID# 225708
San Antonio, Texas 78229
United StatesActive - Recruiting
Next Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.