Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514, Micro Satellite Stable Colorectal Cancer, MSS-CRC, Gastric Cancer, Esophageal Cancer, GEA, GEJ, High-Grade Serous Ovarian Cancer, HGSOC, Pancreatic Cancer, PDAC, Triple Negative Breast Cancer, TNBC, Telisotuzumab Adizutecan, ABBV-400
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGAzirkitug
Intravenous (IV) Infusion
DRUGBudigalimab
Intravenous (IV) Infusion
DRUGBevacizumab
Intravenous (IV) Infusion
Intravenous (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
* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 0 or 1 and a life expectancy of \>= 3 months. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) * Laboratory values meeting criteria outlined in the protocol * NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options. * HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting. * Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient * Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy * High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \>5 lines of prior therapy. * Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple. * Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation
Exclusion criteria
* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE * No major surgery within 28 days prior to dosing * No active autoimmune/immunodeficiency disease with limited exceptions * Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events * Pregnancy * Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE) | Up to 2 Years | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Maximum Observed Serum Concentration (Cmax) of Azirkitug | Up to 2 Years | Maximum Observed Serum Concentration (Cmax) of azirkitug. |
| Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug | Up to 2 Years | Time to maximum Observed Serum Concentration (Tmax) of azirkitug. |
| Terminal Elimination Half-Life (t1/2) of Azirkitug | Up to 2 Years | Terminal elimination half-life (t1/2) of azirkitug. |
| Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug | Up to 2 Years | Area under the serum concentration versus time curve (AUC) of azirkitug. |
| Azirkitug Antidrug Antibody (ADA) | Up to 2 Years | Incidence and concentration of azirkitug anti-drug antibodies. |
| Azirkitug Neutralizing Antidrug Antibody (nADA) | Up to 2 Years | Incidence and concentration of azirkitug neutralizing anti-drug antibodies. |
| Cmax of Budigalimab | Up to 2 Years | Cmax of budigalimab. |
| Tmax of Budigalimab | Up to 2 Years | Tmax of budigalimab. |
| t1/2 of Budigalimab | Up to 2 Years | t1/2 of budigalimab. |
| AUC of Budigalimab | Up to 2 Years | AUC of budigalimab. |
| Budigalimab ADA | Up to 2 Years | Incidence and concentration of budigalimab ADA. |
| Budigalimab nADA | Up to 2 Years | Incidence and concentration of budigalimab nADA. |
| Cmax of Telisotuzumab Adizutecan | Up to 2 Years | Cmax of telisotuzumab adizutecan. |
| Tmax of Telisotuzumab Adizutecan | Up to 2 Years | Tmax of telisotuzumab adizutecan. |
| t1/2 of Telisotuzumab Adizutecan | Up to 2 Years | t1/2 of telisotuzumab adizutecan. |
| AUC of Telisotuzumab Adizutecan | Up to 2 Years | AUC of telisotuzumab adizutecan. |
| Telisotuzumab Adizutecan ADA | Up to 2 Years | Incidence and concentration of telisotuzumab adizutecan ADA. |
| Telisotuzumab Adizutecan nADA | Up to 2 Years | Incidence and concentration of telisotuzumab adizutecan nADA. |
Countries
Canada, Israel, Japan, South Korea, Taiwan, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed