A Phase 1 interventional study of ABBV-011 and Budigalimab in Small Cell Lung Cancer, sponsored by AbbVie. Completed at 32 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 132 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Additional Inclusion Criteria for Study Part B and Part C:
Exclusion Criteria:
Additional Exclusion Criteria for Part C:
Additional exclusion criteria for Japanese and Korean participants:
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.
Drug: ABBV-011
ABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.
Drug: ABBV-011
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.
Drug: ABBV-011 · Drug: Budigalimab
ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.
Drug: ABBV-011
Intravenous
Also known as: SC-011
Intravenous
Also known as: ABBV-181
Number of Participants With Adverse Events
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.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011
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.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab
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.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs are adverse events as described in the protocol.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Mean Change from Baseline in Vital Signs
Mean change from Baseline in vital signs like blood pressure will be assessed.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Incidence of Laboratory Abnormaities
Number of participants with lab abnormalities will be assessed.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Mean Change from Baseline in Electrocardiogram (ECG) Parameters
Mean change from Baseline in ECG parameters like QTc interval will be assessed.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Maximum Serum Concentration (Cmax) of ABBV-011
Maximum Serum Concentration (Cmax) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011
Area under the serum concentration-time curve within a dosing interval of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Area Under the Serum Concentration-Time Curve within a Dosing Interval (AUC0-t) of ABBV-011
Area under the serum concentration-time curve within a dosing interval (AUC0-t) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Time to Maximum Serum Concentration (Tmax) of ABBV-011
Time to maximum serum concentration (Tmax) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Observed Serum Concentration at Trough (Ctrough) of ABBV-011
Observed serum concentration at trough (Ctrough) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Apparent Terminal Half-Life (T1/2) of ABBV-011
Apparent terminal half-life (T1/2) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Accumulation Ratio of ABBV-011
Accumulation ratio of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Serum Clearance (CL) of ABBV-011
Serum clearance of ABBV011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Steady State Volume of Distribution (Vss) of ABBV-011
Steady state volume of distribution (Vss) of ABBV-011.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Incidence of Antidrug Antibodies (ADA) Against ABBV-011 or Budigalimab (ABBV-181)
Number of participants with incidence of ADAs against ABBV-011 or budigalimab will be assessed.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR).
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD).
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Duration of Response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to Progressive Disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Duration of Clinical Benefit (DOCB)
(DOCB) is defined as the time from the participant's initial observation of clinical benefit (CR or PR or SD) to PD or death due to any cause, whichever occurs first.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Progression-Free Survival (PFS)
PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Overall Survival (OS)
OS is defined as the time from the subject's first dose date to death due to any cause.
Time frame: Up to approximately 5 years after the first participant receives first dose of study drug
Plan to share: No
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