Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan (NCT05005403) — South Korea Trial Details

Condition(s) studied

Non-Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaMicro Satellite Stable Colorectal CancerGastric/Esophageal CancerHigh-Grade Serous Ovarian CancerPancreatic CancerTriple Negative Breast Cancer

Investigational drug(s) / intervention(s)

AzirkitugBudigalimab →Bevacizumab →Telisotuzumab Adizutecan →

Azirkitug: Intravenous (IV) Infusion

Budigalimab: Intravenous (IV) Infusion

Bevacizumab: Intravenous (IV) Infusion

Telisotuzumab Adizutecan: Intravenous (IV) Infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (48)

Facility	City	Region	Status
City of Hope National Medical Center /ID# 276272	Duarte	California	Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589	Irvine	California	Recruiting
USC Norris Comprehensive Cancer Center /ID# 279603	Los Angeles	California	Recruiting
University of Illinois Hospital and Health Sciences System /ID# 251750	Chicago	Illinois	Recruiting
University of Chicago Medical Center /ID# 276271	Chicago	Illinois	Recruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593	Fort Wayne	Indiana	Recruiting
Community Health Network, Inc. /ID# 243011	Indianapolis	Indiana	Recruiting
Norton Cancer Institute /ID# 248903	Louisville	Kentucky	Recruiting
START Midwest /ID# 248685	Grand Rapids	Michigan	Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200	Minneapolis	Minnesota	Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399	Omaha	Nebraska	Recruiting
Duke Cancer Institute /ID# 276267	Durham	North Carolina	Recruiting
Carolina BioOncology Institute /ID# 232597	Huntersville	North Carolina	Recruiting
NEXT Oncology Austin /ID# 243005	Austin	Texas	Recruiting
The University of Texas MD Anderson Cancer Center /ID# 270059	Houston	Texas	Recruiting
Next Oncology Dallas /ID# 276254	Irving	Texas	Recruiting
NEXT Oncology /ID# 243007	San Antonio	Texas	Recruiting
South Texas Accelerated Research Therapeutics (START) /ID# 276268	San Antonio	Texas	Recruiting
Start Mountain Region /ID# 276270	West Valley City	Utah	Recruiting
Virginia Cancer Specialists - Fairfax /ID# 232592	Fairfax	Virginia	Recruiting
Tom Baker Cancer Centre /ID# 276206	Calgary	Alberta	Recruiting
Princess Margaret Cancer Centre /ID# 276275	Toronto	Ontario	Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274	Montreal	Quebec	Recruiting
Shamir Medical Center /ID# 276238	Beer Ya'akov	Central District	Recruiting
Meir Medical Center /ID# 277327	Kefar Sava	Central District	Recruiting
Rabin Medical Center. /ID# 250497	Petah Tikva	Central District	Recruiting
The Chaim Sheba Medical Center /ID# 238332	Ramat Gan	Tel Aviv	Recruiting
Tel Aviv Sourasky Medical Center /ID# 276591	Tel Aviv	Tel Aviv	Recruiting
Rambam Health Care Campus /ID# 238333	Haifa	Israel	Recruiting
Shaare Zedek Medical Center /ID# 276244	Jerusalem	Israel	Recruiting
Hadassah Medical Center-Hebrew University /ID# 252287	Jerusalem	Israel	Recruiting
Aichi Cancer Center Hospital /ID# 250405	Nagoya	Aichi-ken	Recruiting
National Cancer Center Hospital East /ID# 238840	Kashiwa-shi	Chiba	Recruiting
Kobe University Hospital /ID# 250409	Kobe	Hyōgo	Recruiting
Kansai Medical University Hospital /ID# 276805	Hirakata-shi	Osaka	Recruiting
Shizuoka Cancer Center /ID# 250408	Sunto-gun	Shizuoka	Recruiting
National Cancer Center Hospital /ID# 238372	Chuo-ku	Tokyo	Recruiting
Wakayama Medical University Hospital /ID# 276806	Wakayama	Wakayama	Completed
National Cancer Center /ID# 252290	Goyang-si	Gyeonggido	Recruiting
CHA Bundang Medical Center /ID# 252291	Seongnam	Gyeonggido	Recruiting

+ 8 more sites — see the full list on the official registry below.

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