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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07241039 | A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors | PHASE1 | RECRUITING | 220 | — | — | Nov 20, 2025 | Oct 1, 2030 | May 19, 2026 | 12 | United States, Canada +2 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-711 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration. |
| Part 2a: ABBV-711 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration. |
| Part 2b: ABBV-711 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration. |
| Part 3: ABBV-711 + BudigalimabDose Escalation | EXPERIMENTAL | Participants will receive ABBV-711 in escalating doses in combination with budigalimab, as part of the 5 year study duration. |
| Part 4a: ABBV-711 Budigalimab Dose Expansion | EXPERIMENTAL | Participants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration. |
| Part 4b: ABBV-711 Budigalimab Dose Expansion | EXPERIMENTAL | Participants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-711 | DRUG | Oral Tablet |
| Budigalimab | DRUG | Intravenous Infusion |
Inclusion Criteria: * Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ineligible for or are intolerant to standard of care therapy are eligible). * Received programmed cell death protein 1 (PD-1)/program...