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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03639194 | A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer | PHASE1 | COMPLETED | 132 | — | — | Oct 24, 2018 | Jan 25, 2024 | Feb 9, 2024 | 32 | United States, Japan +2 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 will be determined during the Part A dose escalation cohort.
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in combination with budigalimab will be determined during the Part C dose escalation cohort.
DLTs are adverse events as described in the protocol.
Mean change from Baseline in vital signs like blood pressure will be assessed.
Number of participants with lab abnormalities will be assessed.
Mean change from Baseline in ECG parameters like QTc interval will be assessed.
| Arm | Type | Description |
|---|---|---|
| Part A: ABBV-011 Dose Escalation | EXPERIMENTAL | ABBV-011 via intravenous administration at various doses and dosing regimens until the maximum tolerated dose and/or the recommended Part B dose(s) is declared. |
| Part B: ABBV-011 Dose Expansion | EXPERIMENTAL | ABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A. |
| Part C: ABBV-011 + Budigalimab Escalation and Expansion | EXPERIMENTAL | ABBV-011 via intravenous administration at various doses and dosing regimens starting at least 1 dose level below the recommended single-agent dose of ABBV-011 for Part B plus Budigalimab via intravenous administration at fixed doses and various dosing regimens. |
| Part D: ABBV-011 Dose Evaluation for Japan | EXPERIMENTAL | ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens. |
| Name | Type | Description |
|---|---|---|
| ABBV-011 | DRUG | Intravenous |
| Budigalimab | DRUG | Intravenous |
Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available. * Measurable disease, de...