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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504714-30 | Other Identifier | EU CT |
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Strategic considerations
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Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).
ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.
In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-303 Dose Escalation: Part 1A Monotherapy | Experimental | Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration. |
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| ABBV-303 Dose Expansion: Part 2A Monotherapy | Experimental | Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration. |
|
| ABBV-303 Dose Expansion: Part 3A Monotherapy | Experimental | Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration. |
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| ABBV-303 Dose Expansion: Part 4A Monotherapy | Experimental | Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration. |
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| ABBV-303 Dose Expansion: Part 5A Monotherapy | Experimental | Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-303 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to RECIST version 1.1. | Up to 3 Years |
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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 |
|---|---|---|---|---|---|---|
| City of Hope /ID# 254303 | Duarte | California | 91010 | United States | ||
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792 |
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| ABBV-303 Dose Escalation: Part 1B Combination | Experimental | Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration. |
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| ABBV-303 Dose Expansion: Part 2B Combination | Experimental | Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration. |
|
| Budigalimab | Drug | IV Infusion |
|
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| Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 |
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier. |
| Up to 3 Years |
| Progression-free survival (PFS) | PFS is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier. | Up to 3 Years |
| Overall survival (OS) | OS is defined as time from first study treatment to death due to any cause. | Up to 3 Years |
| ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST) | ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to iRECIST version 1.1. | Up to 3 Years |
| Irvine |
| California |
| 92618 |
| United States |
| University of Southern California /ID# 254356 | Los Angeles | California | 90033 | United States |
| START Midwest /ID# 256945 | Grand Rapids | Michigan | 49546-7062 | United States |
| Washington University-School of Medicine /ID# 262943 | St Louis | Missouri | 63110 | United States |
| NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943 | New York | New York | 10016 | United States |
| Carolina BioOncology Institute /ID# 254305 | Huntersville | North Carolina | 28078 | United States |
| The Ohio State University - The James /ID# 260475 | Columbus | Ohio | 43210-1240 | United States |
| University of Texas MD Anderson Cancer Center /ID# 254308 | Houston | Texas | 77030 | United States |
| NEXT Oncology /ID# 257395 | San Antonio | Texas | 78229 | United States |
| South Texas Accelerated Research Therapeutics /ID# 256944 | San Antonio | Texas | 78229 | United States |
| The Chaim Sheba Medical Center /ID# 259408 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus /ID# 254608 | Haifa | 3109601 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 254606 | Jerusalem | 91120 | Israel |
| National Cancer Center Hospital East /ID# 261712 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Shizuoka Cancer Center /ID# 261714 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital /ID# 254359 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Wakayama Medical University Hospital /ID# 254361 | Wakayama | Wakayama | 641-8510 | Japan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
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