Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04777994 | RECRUITING | Advanced Solid Tumor Cancer

Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Sponsor:

AbbVie

Brief Summary:

The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). 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.

Condition or disease

Advanced Solid Tumor Cancer

Intervention/treatment

ABBV-CLS-484

Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)

Programmed Cell Death-1 (PD-1) Inhibitor

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 248 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Actual Study Start Date : 2021-03-09
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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), 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
                • * 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 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.
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors

Location Details

NCT04777994

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

University of Arizona Cancer Center - Tucson /ID# 262698

Tucson, Arizona, United States, 85724

RECRUITING

United States, Connecticut

Yale University School of Medicine /ID# 225707

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Maryland

Johns Hopkins Hospital /ID# 254056

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center /ID# 252009

Boston, Massachusetts, United States, 02215-5400

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute /ID# 249642

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, New York

NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869

New York, New York, United States, 10016

RECRUITING

United States, North Carolina

Duke Cancer Center /ID# 251975

Durham, North Carolina, United States, 27710

COMPLETED

United States, North Carolina

Carolina BioOncology Institute /ID# 225704

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, Pennsylvania

Perelman Center for Advanced Medicine /ID# 250188

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Ctr /ID# 225706

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Rhode Island

Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705

Providence, Rhode Island, United States, 02903-4923

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center /ID# 251974

Dallas, Texas, United States, 75390-7208

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center /ID# 252004

Houston, Texas, United States, 77030

COMPLETED

United States, Texas

NEXT Oncology /ID# 225708

San Antonio, Texas, United States, 78229

RECRUITING

France, Bouches-du-Rhone

Institut paoli-calmettes / id # 260956

Marseille, Bouches-du-Rhone, France, 13009

RECRUITING

France, Occitania

IUCT Oncopole /ID# 252673

Toulouse Cedex 9, Occitanie, France, 31059

RECRUITING

France, Provence-Alpes-Cote-d Azur

Antoine-Lacassagne center /ID# 252606

Nice, Provence-Alpes-Cote-d Azur, France, 06189

RECRUITING

France,

HOPITAL FOCH /ID# 252607

Suresnes Cedex, France, 92151

RECRUITING

Israel, Hamerkaz

Rabin Medical Center /ID# 263631

Heels of a tip, Hamerkaz, Israel, 4941492

RECRUITING

Israel, Tel-Aviv

The Chaim Sheba Medical Center /ID# 226756

Ramat Gain, Tel-Aviv, Israel, 5265601

RECRUITING

Israel, Yerushalayim

Hadassah Medical Center /ID# 252366

Jerusalem, Yerushalayim, Israel, 91120

RECRUITING

Japan, Tokyo

National Cancer Center Hospital /ID# 225884

C-Cry, Tokyo, Japan, 104-0045

RECRUITING

Japan, Wakayama

Wakayama Medical University Hospital /ID# 252988

Mr. Wakayama, Wakayama, Japan, 641-8510

RECRUITING

Korea, Republic of, Seoul Teugbyeolsi

Seoul National University Hospital /ID# 254635

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080

RECRUITING

Korea, Republic of, Seoul Teugbyeolsi

Samsung Medical Center /ID# 260664

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351

RECRUITING

Korea, Republic of,

Yonsei University Health System Severance Hospital /ID# 260665

Seoul, Korea, Republic of, 03722

RECRUITING

Spain, Barcelona

Catalan Institute of Oncology (ICO) - The Hospitalet /ID#

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

RECRUITING

Spain,

OCTOBER 12 UNIVERSITY HOSPITAL /ID# 257374

Madrid, Spain, 28041

RECRUITING

Spain,

HM Sanchinarro University Hospital /ID# 228034

Madrid, Spain, 28050