Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
NCT ID: NCT04777994
Last Updated: 2025-12-23
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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RECRUITING
PHASE1
248 participants
INTERVENTIONAL
2021-03-09
2026-10-31
Brief Summary
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The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).
Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.
Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.
Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
ABBV-CLS-484 will be administered as a monotherapy in subjects with solid tumors
ABBV-CLS-484
Oral Capsule
Combination Dose Escalation with PD-1 Inhibitor
ABBV-CLS-484 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
ABBV-CLS-484
Oral Capsule
Programmed Cell Death-1 (PD-1) Inhibitor
Intravenous (IV) infusion
Monotherapy Expansion
ABBV-CLS-484 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC)
ABBV-CLS-484
Oral Capsule
Combination Expansion with PD-1 Inhibitor
ABBV-CLS-484 will be administered at the determined recommended dose in combination with Programmed Cell Death-1 Inhibitor in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
ABBV-CLS-484
Oral Capsule
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Oral Tablet
Combination Dose Escalation with VEGFR TKI
ABBV-CLS-484 will be administered in combination with a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) in subjects with solid tumors
ABBV-CLS-484
Oral Capsule
Programmed Cell Death-1 (PD-1) Inhibitor
Intravenous (IV) infusion
Combination Expansion
ABBV-CLS-484 will be administered at the determined recommended dose in combination with VEGFR TKI in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
ABBV-CLS-484
Oral Capsule
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Oral Tablet
Interventions
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ABBV-CLS-484
Oral Capsule
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Oral Tablet
Programmed Cell Death-1 (PD-1) Inhibitor
Intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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), and no 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 locally 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
* 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 study treatment and felt to be at low recurrence by investigator.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of 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) infection per local testing practices.
18 Years
ALL
No
Sponsors
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Calico Life Sciences LLC
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Arizona Cancer Center - Tucson /ID# 262698
Tucson, Arizona, United States
Yale University School of Medicine /ID# 225707
New Haven, Connecticut, United States
Johns Hopkins Hospital /ID# 254056
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center /ID# 252009
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 249642
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010
Ann Arbor, Michigan, United States
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869
New York, New York, United States
Duke Cancer Center /ID# 251975
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 225704
Huntersville, North Carolina, United States
Perelman Center for Advanced Medicine /ID# 250188
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 225706
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center /ID# 251974
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 252004
Houston, Texas, United States
NEXT Oncology /ID# 225708
San Antonio, Texas, United States
Institut Paoli-Calmettes /ID# 260956
Marseille, Bouches-du-Rhone, France
IUCT Oncopole /ID# 252673
Toulouse, Occitanie, France
Centre Antoine-Lacassagne /ID# 252606
Nice, Provence-Alpes-Côte d'Azur Region, France
Hopital Foch /ID# 252607
Suresnes, , France
Rabin Medical Center /ID# 263631
Petah Tikva, Central District, Israel
Hadassah Medical Center /ID# 252366
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 226756
Ramat Gan, Tel Aviv, Israel
National Cancer Center Hospital /ID# 225884
Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 252988
Wakayama, Wakayama, Japan
Seoul National University Hospital /ID# 254635
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 260664
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 260665
Seoul, , South Korea
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 257374
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 228034
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
References
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Baumgartner CK, Ebrahimi-Nik H, Iracheta-Vellve A, Hamel KM, Olander KE, Davis TGR, McGuire KA, Halvorsen GT, Avila OI, Patel CH, Kim SY, Kammula AV, Muscato AJ, Halliwill K, Geda P, Klinge KL, Xiong Z, Duggan R, Mu L, Yeary MD, Patti JC, Balon TM, Mathew R, Backus C, Kennedy DE, Chen A, Longenecker K, Klahn JT, Hrusch CL, Krishnan N, Hutchins CW, Dunning JP, Bulic M, Tiwari P, Colvin KJ, Chuong CL, Kohnle IC, Rees MG, Boghossian A, Ronan M, Roth JA, Wu MJ, Suermondt JSMT, Knudsen NH, Cheruiyot CK, Sen DR, Griffin GK, Golub TR, El-Bardeesy N, Decker JH, Yang Y, Guffroy M, Fossey S, Trusk P, Sun IM, Liu Y, Qiu W, Sun Q, Paddock MN, Farney EP, Matulenko MA, Beauregard C, Frost JM, Yates KB, Kym PR, Manguso RT. The PTPN2/PTPN1 inhibitor ABBV-CLS-484 unleashes potent anti-tumour immunity. Nature. 2023 Oct;622(7984):850-862. doi: 10.1038/s41586-023-06575-7. Epub 2023 Oct 4.
Related Links
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Other Identifiers
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2023-507568-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
M20-431
Identifier Type: -
Identifier Source: org_study_id