First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Calico Life Sciences LLC.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
101actual
Sites
17
Countries
France, Israel, Japan +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-03 | actual | When the study began enrolling |
| Primary completion | 2025-08-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-21 | actual | The whole study's end, after follow-up |
| First posted | 2020-06-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumors Cancer
Interventions
- Drug: ABBV-CLS-579
- Drug: PD-1 inhibitor
- Drug: VEGFR TKI
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579
measured Baseline Up to Approximately Day 44
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4
measured Baseline Up to Approximately Day 44
Maximum Observed Plasma/Serum Concentration (Cmax) Of PD-1 Inhibitor
measured Baseline Up to Approximately Day 64
Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFR TKI
measured Baseline Up to Approximately Day 64
Time To Cmax (Tmax) Of ABBV-CLS-579
measured Baseline Up to Approximately Day 44
Time To Cmax (Tmax) Of Metabolite M4
measured Baseline Up to Approximately Day 44
Time To Cmax (Tmax) Of PD-1 Inhibitor
measured Baseline Up to Approximately Day 64
Time To Cmax (Tmax) Of VEGFR TKI
measured Baseline Up to Approximately Day 64
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579
measured Baseline Up to Approximately Day 44
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4
measured Baseline Up to Approximately Day 44
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor
measured Baseline Up to Approximately Day 64
Terminal Phase Elimination Rate Constant (β) Of VEGFR TKI
measured Baseline Up to Approximately Day 64
Terminal Phase Elimination Half-Life (t1/2) Of ABBV-CLS-579
measured Baseline Up to Approximately Day 44
Terminal Phase Elimination Half-Life (t1/2) Of Metabolite M4
measured Baseline Up to Approximately Day 44
Terminal Phase Elimination Half-Life (t1/2) Of PD-1 Inhibitor
measured Baseline Up to Approximately Day 64
Terminal Phase Elimination Half-Life (t1/2) Of VEGFR TKI
measured Baseline Up to Approximately Day 64
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579
measured Baseline Up to Approximately Day 44
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4
measured Baseline Up to Approximately Day 44
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor
measured Baseline Up to Approximately Day 64
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI
measured Baseline Up to Approximately Day 64
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579
measured Baseline through Study Completion (approximately 3 years)
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor
measured Baseline through Study Completion (approximately 3 years)
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Base On Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ABBV-CLS-579 in locally or metastatic HNSCC, NSCLC, MSI-H tumors, and advanced ccRCC
measured Baseline through Study Completion (approximately 3 years)
Objective Response Rate (ORR) on RECIST v1.1, of ABBV-CLS-579 administered in combination with VEGFR TKI in advanced ccRCC
measured Baseline through Study Completion (approximately 3 years)
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