Solid Tumors Clinical Trial
Official title:
A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors
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.
| Status | Recruiting |
| Enrollment | 192 |
| Est. completion date | January 19, 2028 |
| Est. primary completion date | January 19, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug. - Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria). - Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Exclusion Criteria: - Unresolved Grade > 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia. - Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy. - History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181). - Body weight < 35 kg. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Health Care Campus /ID# 254608 | Haifa | H_efa |
| Israel | Hadassah Medical Center-Hebrew University /ID# 254606 | Jerusalem | |
| Israel | The Chaim Sheba Medical Center /ID# 259408 | Ramat Gan | Tel-Aviv |
| Japan | National Cancer Center Hospital /ID# 254359 | Chuo-ku | Tokyo |
| Japan | National Cancer Center Hospital East /ID# 261712 | Kashiwa-shi | Chiba |
| Japan | Shizuoka Cancer Center /ID# 261714 | Sunto-gun | Shizuoka |
| Japan | Wakayama Medical University Hospital /ID# 254361 | Wakayama-shi | Wakayama |
| United States | The Ohio State University - The James /ID# 260475 | Columbus | Ohio |
| United States | City of Hope /ID# 254303 | Duarte | California |
| United States | START Midwest /ID# 256945 | Grand Rapids | Michigan |
| United States | University of Texas MD Anderson Cancer Center /ID# 254308 | Houston | Texas |
| United States | Carolina BioOncology Institute /ID# 254305 | Huntersville | North Carolina |
| United States | City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792 | Irvine | California |
| United States | University of Southern California /ID# 254356 | Los Angeles | California |
| United States | Washington University-School of Medicine /ID# 262943 | Saint Louis | Missouri |
| United States | NEXT Oncology /ID# 257395 | San Antonio | Texas |
| United States | South Texas Accelerated Research Therapeutics /ID# 256944 | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Israel, Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Overall survival (OS) | OS is defined as time from first study treatment to death due to any cause. | Up to 3 Years | |
| Secondary | 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 |
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