NCT05005403
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.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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
