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

Launched by ABBVIE · Feb 26, 2021

Keywords

ClinConnect Summary

This clinical trial is examining a new treatment called ABBV-CLS-484 for patients with advanced solid tumor cancers, which are tumors that have spread beyond their original location. The study is being conducted in three parts: first, to find the safest dose of ABBV-CLS-484 when given alone; second, to see how it works when combined with other treatments that target the immune system or blood vessel growth; and third, to further evaluate the best doses in specific types of cancer, such as head and neck cancer, lung cancer, and kidney cancer.

To participate, individuals must be at least 35 kilograms in weight, have a life expectancy of at least 12 weeks, and have advanced tumors that haven’t responded to standard therapies. Participants can expect to receive either the new treatment alone or in combination with other therapies, depending on the part of the trial they are in. It’s important to note that those with certain health conditions or a recent history of severe medical issues may not be eligible. This trial is currently recruiting participants who meet the criteria.

Gender

ALL

Eligibility 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.