Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04417465 | First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors | PHASE1 | COMPLETED | 101 | — | — | Jun 3, 2020 | Aug 21, 2025 | Sep 25, 2025 | 17 | United States, France +5 |
Maximum plasma/serum concentration of ABBV-CLS-579
Maximum plasma/serum concentration of Metabolite M4
Maximum plasma/serum concentration of PD-1 inhibitor
Maximum plasma/serum concentration of VEGFR TKI
The amount of time taken to reach Cmax
The amount of time taken to reach Cmax
The amount of time taken to reach Cmax
The amount of time taken to reach Cmax
Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination rate constant (β or Beta)
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2)
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
The Expansion Dose and/or MTD of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
The Expansion Dose and/or MTD of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
| Arm | Type | Description |
|---|---|---|
| Monotherapy Dose Escalation | EXPERIMENTAL | ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors |
| Combination Dose Escalation with PD-1 | EXPERIMENTAL | ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors |
| Backfill Cohorts with Monotherapy | EXPERIMENTAL | ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors |
| Backfill Cohorts in Combination with PD-1 | EXPERIMENTAL | ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors |
| Combination Expansion with PD-1 | EXPERIMENTAL | ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC) |
| Combination Expansion with VEGFR TKI | EXPERIMENTAL | ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC. |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-579 | DRUG | Oral Capsule |
| PD-1 inhibitor | DRUG | Intravenous (IV) infusion |
| VEGFR TKI | DRUG | Oral Tablet |
Inclusion Criteria: * Must weigh at least 35 kilograms (kg). * For Monotherapy and Combination Dose Escalation: * Histologically or cytologically proven metastatic or locally advanced tumors (with measurable disease defined by Response Evaluation Criteria In Solid Tumors \[RECIST\] v1.1), for wh...