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ABBV-011 · 1 trial · 1 indication
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...
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ABBV-011 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer (SCLC). It is being evaluated in patients with relapsed or refractory SCLC, meaning the cancer has returned or has not responded to prior treatment. The drug is still in clinical development and is not yet approved.
ABBV-011 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with Small Cell Lung Cancer.
ABBV-011 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still being evaluated for its safety and potential effectiveness in treating Small Cell Lung Cancer.
ABBV-011 has been studied in a Phase 1 clinical trial with the identifier NCT03639194. This trial evaluated ABBV-011 alone and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory Small Cell Lung Cancer. The trial was completed and enrolled 132 participants across the United States, Japan, South Korea, and Taiwan.
No, ABBV-011 is not the same as budigalimab. ABBV-011 is a small molecule being studied as a single agent and in combination with budigalimab (also known as ABBV-181) in a clinical trial for Small Cell Lung Cancer. Budigalimab is a separate investigational drug used in combination with ABBV-011 in that trial.