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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001461-88 | EudraCT Number |
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This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). |
|
| Arm A, B, and C | Experimental | Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428. |
|
| Arm D | Experimental | Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab. |
|
| Arm 2 | Experimental | ABBV-428 plus nivolumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-428 | Drug | ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose | |
| Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab | If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data. | 1 day of study drug administration within the 28-day cycle at the designated cohort dose |
| Area under the serum concentration-time curve (AUC) of ABBV-428 | Up to 30 days after a 24-month treatment period | |
| Terminal half-life (t1/2) of ABBV-428 | Up to 30 days after a 24-month treatment period | |
| Maximum observed serum concentration (Cmax) of ABBV-428 | Up to 30 days after a 24-month treatment period | |
| Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab | The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity. | Up to 2 years |
| Time to Cmax (Tmax) of ABBV-428 | Up to 30 days after a 24-month treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response (DOR) | DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first. | Up to 30 days after a 24-month of treatment period |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Pima /ID# 155461 | Scottsdale | Arizona | 85258-2345 | United States | ||
| UC Davis Comprehensive Cancer Center - Main /ID# 154439 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33608377 | Derived | Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015. |
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| Nivolumab | Drug | Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules. |
|
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CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
| Up to 30 days after a 24-month of treatment period |
| Progression-Free Survival (PFS) | PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first | Up to 30 days after a 24-month of treatment period |
| Objective Response Rate (ORR) | ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. | Up to 30 days after a 24-month of treatment period |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Chicago /ID# 154440 | Chicago | Illinois | 60637-1443 | United States |
| Fox Chase Cancer Center /ID# 170665 | Philadelphia | Pennsylvania | 19111 | United States |
| Greenville Hospital System /ID# 154437 | Greenville | South Carolina | 29605 | United States |
| MD Anderson Cancer Center at Texas Medical Center /ID# 154441 | Houston | Texas | 77030-4000 | United States |
| South Texas Accelerated Research Therapeutics /ID# 154442 | San Antonio | Texas | 78229 | United States |
| Chris O'Brien Lifehouse /ID# 163131 | Camperdown | New South Wales | 2050 | Australia |
| Northern Cancer Institute /ID# 163132 | St Leonards | New South Wales | 2065 | Australia |
| Institut Bergonie /ID# 202391 | Bordeaux | Gironde | 33000 | France |
| Hopital de la Timone /ID# 162256 | Marseille | Provence-Alpes-Côte d'Azur Region | 13385 | France |
| Centre Leon Berard /ID# 168072 | Lyon | Rhone | 69373 | France |
| Institut Curie /ID# 162258 | Paris | Île-de-France Region | 75248 | France |
| Gustave Roussy /ID# 162257 | Villejuif | Île-de-France Region | 94805 | France |
| National Taiwan Univ Hosp /ID# 169034 | Taipei City | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian 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 |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000720853 | ABBV-428 |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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