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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417465
Recruitment Status : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Calico Life Sciences LLC

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE June 3, 2020
Estimated Primary Completion Date April 6, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    Maximum plasma/serum concentration of ABBV-CLS-579
  • Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    Maximum plasma/serum concentration of PD-1 inhibitor
  • Time To Cmax (Tmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    The amount of time taken to reach Cmax
  • Time To Cmax (Tmax) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    The amount of time taken to reach Cmax
  • Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    Terminal phase elimination rate constant (β or Beta)
  • Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    Terminal phase elimination rate constant (β or Beta)
  • Terminal Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    Terminal phase elimination half-life (t1/2)
  • Terminal Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    Terminal phase elimination half-life (t1/2)
  • Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
  • Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
  • Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
    The MTD and/or RP2D of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
  • Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
    The MTD and/or RP2D of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • 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) ]
    ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
  • 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) ]
    ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
  • Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1 [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
    BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
  • 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) ]
    BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
  • Change from Baseline QTc [ Time Frame: Baseline Up to Approximately Day 44 ]
    QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors Cancer
Intervention  ICMJE
  • Drug: ABBV-CLS-579
    Oral Capsule
  • Drug: Programmed Cell Death-1 (PD-1) Inhibitor
    Intravenous (IV) infusion
Study Arms  ICMJE
  • Experimental: ABBV-CLS-579 Monotherapy
    Participants will receive escalating doses of ABBV-CLS-579
    Intervention: Drug: ABBV-CLS-579
  • Experimental: ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor
    Participants will receive escalating doses of ABBV-CLS-579 and PD-1 inhibitor.
    Interventions:
    • Drug: ABBV-CLS-579
    • Drug: Programmed Cell Death-1 (PD-1) Inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 6, 2023
Estimated Primary Completion Date April 6, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04417465
Other Study ID Numbers  ICMJE M20-124
2020-000639-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Calico Life Sciences LLC
Study Sponsor  ICMJE Calico Life Sciences LLC
Collaborators  ICMJE AbbVie
Investigators  ICMJE Not Provided
PRS Account Calico Life Sciences LLC
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP