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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-011 | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to approximately 5 years after the first participant receives first dose of study drug |
| Mean Change from Baseline in Vital Signs |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of ABBV-011 | Maximum Serum Concentration (Cmax) of ABBV-011. | 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 |
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Inclusion Criteria:
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:
- Participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 207295 | Birmingham | Alabama | 35233 | United States | ||
| Highlands Oncology Group, PA /ID# 207176 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35642431 | Derived | Wiedemeyer WR, Gavrilyuk J, Schammel A, Zhao X, Sarvaiya H, Pysz M, Gu C, You M, Isse K, Sullivan T, French D, Lee C, Dang AT, Zhang Z, Aujay M, Bankovich AJ, Vitorino P. ABBV-011, A Novel, Calicheamicin-Based Antibody-Drug Conjugate, Targets SEZ6 to Eradicate Small Cell Lung Cancer Tumors. Mol Cancer Ther. 2022 Jun 1;21(6):986-998. doi: 10.1158/1535-7163.MCT-21-0851. |
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|
| Budigalimab | Drug | Intravenous |
|
|
Mean change from Baseline in vital signs like blood pressure will be assessed. |
| 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. | 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. | 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 of ABBV-011. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | Up to approximately 5 years after the first participant receives first dose of study drug |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| University of California, Davis Comprehensive Cancer Center /ID# 207548 | Sacramento | California | 95817 | United States |
| Yale School of Medicine /ID# 207559 | New Haven | Connecticut | 06519 | United States |
| University of Iowa Hospitals and Clinics /ID# 207560 | Iowa City | Iowa | 52242 | United States |
| University of Kentucky Chandler Medical Center /ID# 208217 | Lexington | Kentucky | 40536 | United States |
| Massachusetts General Hospital /ID# 207549 | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute /ID# 213032 | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center /ID# 207177 | Ann Arbor | Michigan | 48109-5000 | United States |
| Henry Ford Hospital /ID# 233539 | Detroit | Michigan | 48202 | United States |
| Washington University-School of Medicine /ID# 207168 | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216 | New York | New York | 10065-6007 | United States |
| Duke Cancer Center /ID# 207547 | Durham | North Carolina | 27710 | United States |
| UH Cleveland Medical Center /ID# 207561 | Cleveland | Ohio | 44106 | United States |
| The Ohio State University /ID# 207552 | Columbus | Ohio | 43210 | United States |
| Tennessee Oncology, PLLC /ID# 207175 | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Ingram Cancer Center /ID# 207551 | Nashville | Tennessee | 37232-0021 | United States |
| NEXT Oncology /ID# 207167 | San Antonio | Texas | 78229 | United States |
| University of Utah /ID# 207553 | Salt Lake City | Utah | 84112-5500 | United States |
| University of Washington /ID# 207557 | Seattle | Washington | 98109 | United States |
| Univ of Wisconsin Hosp/Clinics /ID# 207556 | Madison | Wisconsin | 53792-0001 | United States |
| National Cancer Center Hospital East /ID# 230943 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center /ID# 229737 | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido Cancer Center /ID# 229101 | Sapporo | Hokkaido | 003-0804 | Japan |
| Shizuoka Cancer Center /ID# 230911 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Wakayama Medical University Hospital /ID# 229111 | Wakayama | Wakayama | 641-8510 | Japan |
| National Cancer Center /ID# 240169 | Goyang | Gyeonggido | 10408 | South Korea |
| Seoul National University Bundang Hospital /ID# 234274 | Seongnam | Gyeonggido | 13620 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 239515 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Seoul National University Hospital /ID# 234272 | Seoul | 03080 | South Korea |
| Asan Medical Center /ID# 234273 | Seoul | 05505 | South Korea |
| National Cheng Kung University Hospital /ID# 234267 | Tainan | 704 | Taiwan |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
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