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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

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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Drug: ABBV-CLS-579 Drug: Programmed Cell Death-1 (PD-1) Inhibitor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2020
Estimated Primary Completion Date : April 6, 2023
Estimated Study Completion Date : April 6, 2023

Arm Intervention/treatment
Experimental: ABBV-CLS-579 Monotherapy
Participants will receive escalating doses of ABBV-CLS-579
Drug: ABBV-CLS-579
Oral Capsule

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.
Drug: ABBV-CLS-579
Oral Capsule

Drug: Programmed Cell Death-1 (PD-1) Inhibitor
Intravenous (IV) infusion




Primary Outcome Measures :
  1. 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

  2. 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

  3. Time To Cmax (Tmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
    The amount of time taken to reach Cmax

  4. Time To Cmax (Tmax) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
    The amount of time taken to reach Cmax

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417465


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Israel
Sheba Medical Center
Ramat Gan, Israel, 5262100
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Calico Life Sciences LLC
AbbVie
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Responsible Party: Calico Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04417465    
Other Study ID Numbers: M20-124
2020-000639-28 ( EudraCT Number )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Calico Life Sciences LLC:
Cancer
Tumor
ABBV-CLS-579
anti-PD-1
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes