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
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ClinicalTrials.gov Identifier: NCT04417465 |
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : November 25, 2020
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Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Advanced Solid Tumors Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 |