Clinical Trials /

First In Human Study With ABBV-CLS-579 When Given Alone Or In Combination With Programmed Cell Death-1 Inhibitor In Participants With Locally Advanced Or Metastatic Tumors

NCT04417465

Description:

The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone or in combination with programmed cell death protein-1 (PD-1) inhibitors in treating solid cancers. ABBV-CLS-579 is an investigational drug being developed for the treatment of solid tumors. The study has two arms - Monotherapy and Combination Therapy. In the monotherapy arm, participants will receive ABBV-CLS-579 alone, in increasing doses. In the combination therapy arm, escalating doses of ABBV-CLS-579 will be given in combination with a PD-1 inhibitor. Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists, or has failed will be enrolled. Participants will receive oral ABBV-CLS-579 capsule alone or in combination with intravenous (IV) PD-1 inhibitor. Participants will receive study drug treatment until disease progresses or discontinued. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First In Human Study With ABBV-CLS-579 When Given Alone Or In Combination With Programmed Cell Death-1 Inhibitor In Participants With Locally Advanced Or Metastatic Tumors
  • Official Title: A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination With Anti-PD-1 in Subjects With Locally Advanced or Metastatic Tumors

Clinical Trial IDs

  • ORG STUDY ID: M20-124
  • SECONDARY ID: 2020-000639-28
  • NCT ID: NCT04417465

Conditions

  • Advanced Solid Tumors Cancer

Interventions

DrugSynonymsArms
ABBV-CLS-579ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor
Programmed Cell Death-1 (PD-1) InhibitorABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor

Purpose

The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone or in combination with programmed cell death protein-1 (PD-1) inhibitors in treating solid cancers. ABBV-CLS-579 is an investigational drug being developed for the treatment of solid tumors. The study has two arms - Monotherapy and Combination Therapy. In the monotherapy arm, participants will receive ABBV-CLS-579 alone, in increasing doses. In the combination therapy arm, escalating doses of ABBV-CLS-579 will be given in combination with a PD-1 inhibitor. Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists, or has failed will be enrolled. Participants will receive oral ABBV-CLS-579 capsule alone or in combination with intravenous (IV) PD-1 inhibitor. Participants will receive study drug treatment until disease progresses or discontinued. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Trial Arms

NameTypeDescriptionInterventions
ABBV-CLS-579 MonotherapyExperimentalParticipants will receive escalating doses of ABBV-CLS-579
  • ABBV-CLS-579
ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) InhibitorExperimentalParticipants will receive escalating doses of ABBV-CLS-579 and PD-1 inhibitor.
  • ABBV-CLS-579
  • Programmed Cell Death-1 (PD-1) Inhibitor

Eligibility Criteria

        Inclusion Criteria:

          -  Must weigh at least 35 kilograms (kg).

          -  Histologically or cytologically proven metastatic or locally advanced tumors (with
             measurable disease defined by Response Evaluation Criteria In Solid Tumors [RECIST]
             v1.1), for which no effective standard therapy exists, or where standard therapy has
             failed. Participants must have received at least 1 prior anticancer therapy for the
             indication being considered.

          -  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 < 450 msec (using Fridericia's correction), and
             no clinically significant electrocardiographic findings.

        Exclusion Criteria:

          -  Untreated brain or meningeal metastases (participants 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.

          -  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, pericardial
             effusion, pericarditis or clinically significant 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 participation in
             this study or would make the participant an unsuitable candidate to receive study
             drug.

          -  Known gastrointestinal disorders making absorption of oral medications problematic.
             Inability to swallow capsules.

          -  If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell death
             protein-ligand 1(aPD-L1) targeting or other immunostimulatory 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 interstitial lung disease or pneumonitis.

          -  Major surgery ≤ 28 days prior to first dose of study drug.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579
Time Frame:Baseline Up to Approximately Day 44
Safety Issue:
Description:Maximum plasma/serum concentration of ABBV-CLS-579

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time Frame:Baseline through Study Completion (approximately 3 years)
Safety Issue:
Description:ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measure:Objective Response Rate (ORR) Of ABBV-CLS-579 Monotherapy Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time Frame:Baseline through Study Completion (approximately 3 years)
Safety Issue:
Description:ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measure:Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
Time Frame:Baseline through Study Completion (approximately 3 years)
Safety Issue:
Description:BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Measure:Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1
Time Frame:Baseline through Study Completion (approximately 3 years)
Safety Issue:
Description:BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Measure:Change from Baseline QTc
Time Frame:Baseline Up to Approximately Day 44
Safety Issue:
Description:QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Calico Life Sciences LLC

Trial Keywords

  • Cancer
  • Tumor
  • ABBV-CLS-579
  • anti-PD-1

Last Updated

June 10, 2020