Solid Tumors
Conditions
Keywords
Solid Tumors, Non-Small Cell Lung Cancer, NSCLC, Renal Cell Carcinoma, RCC, Head and Neck Squamous Cell Carcinoma, HNSCC, ABBV-303, ABBV-181, Budigalimab
Brief summary
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.
Interventions
DRUGABBV-303
Intravenous (IV) Infusion
DRUGBudigalimab
IV Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AE) | Up to 3 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 3 Years | 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. |
| Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 | Up to 3 Years | 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. |
| Progression-free survival (PFS) | Up to 3 Years | 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. |
| Overall survival (OS) | Up to 3 Years | OS is defined as time from first study treatment to death due to any cause. |
| ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST) | Up to 3 Years | 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. |
Countries
Israel, Japan, United States
Outcome results
None listed