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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation: Azirkitug | Experimental | Participants will receive Azirkitug. |
|
| Part 1 Dose Escalation: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. |
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| Part 2 Dose Expansion: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
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| Part 2 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
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| Part 3 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azirkitug | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) | 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. | Up to 2 Years |
| Maximum Observed Serum Concentration (Cmax) of Azirkitug | Maximum Observed Serum Concentration (Cmax) of azirkitug. | Up to 2 Years |
| Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug | Time to maximum Observed Serum Concentration (Tmax) of azirkitug. | Up to 2 Years |
| Terminal Elimination Half-Life (t1/2) of Azirkitug | Terminal elimination half-life (t1/2) of azirkitug. | Up to 2 Years |
| Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug | Area under the serum concentration versus time curve (AUC) of azirkitug. | Up to 2 Years |
| Azirkitug Antidrug Antibody (ADA) | Incidence and concentration of azirkitug anti-drug antibodies. | Up to 2 Years |
| Azirkitug Neutralizing Antidrug Antibody (nADA) | Incidence and concentration of azirkitug neutralizing anti-drug antibodies. | Up to 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center /ID# 276272 | Recruiting | Duarte | California | 91010 | United States | |
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| Part 4 Dose Expansion: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
|
| Part 4 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. |
|
| Part 4 Dose Optimization and Randomization: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
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| Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. |
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| Part 5 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
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| Part 6 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
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| Part 7 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
|
| Part 8 Safety Lead In: Azirkitug + Bevacizumab | Experimental | Participants will receive Azirkitug in combination with bevacizumab. |
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| Part 8 Dose Expansion: Azirkitug + Bevacizumab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab. |
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| Part 9 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
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| Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan | Experimental | Participants will receive Azirkitug in combination with telisotuzumab adizutecan. |
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| Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan | Experimental | Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan. |
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| Budigalimab | Drug | Intravenous (IV) Infusion |
|
| Bevacizumab | Drug | Intravenous (IV) Infusion |
|
| Telisotuzumab Adizutecan | Drug | Intravenous (IV) Infusion |
|
| Cmax of Budigalimab | Cmax of budigalimab. | Up to 2 Years |
| Tmax of Budigalimab | Tmax of budigalimab. | Up to 2 Years |
| t1/2 of Budigalimab | t1/2 of budigalimab. | Up to 2 Years |
| AUC of Budigalimab | AUC of budigalimab. | Up to 2 Years |
| Budigalimab ADA | Incidence and concentration of budigalimab ADA. | Up to 2 Years |
| Budigalimab nADA | Incidence and concentration of budigalimab nADA. | Up to 2 Years |
| Cmax of Telisotuzumab Adizutecan | Cmax of telisotuzumab adizutecan. | Up to 2 Years |
| Tmax of Telisotuzumab Adizutecan | Tmax of telisotuzumab adizutecan. | Up to 2 Years |
| t1/2 of Telisotuzumab Adizutecan | t1/2 of telisotuzumab adizutecan. | Up to 2 Years |
| AUC of Telisotuzumab Adizutecan | AUC of telisotuzumab adizutecan. | Up to 2 Years |
| Telisotuzumab Adizutecan ADA | Incidence and concentration of telisotuzumab adizutecan ADA. | Up to 2 Years |
| Telisotuzumab Adizutecan nADA | Incidence and concentration of telisotuzumab adizutecan nADA. | Up to 2 Years |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589 |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| USC Norris Comprehensive Cancer Center /ID# 279603 | Recruiting | Los Angeles | California | 90033 | United States |
| University of Illinois Hospital and Health Sciences System /ID# 251750 | Recruiting | Chicago | Illinois | 60607 | United States |
| University of Chicago Medical Center /ID# 276271 | Recruiting | Chicago | Illinois | 60637 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 | Recruiting | Fort Wayne | Indiana | 46804 | United States |
| Community Health Network, Inc. /ID# 243011 | Recruiting | Indianapolis | Indiana | 46250-2042 | United States |
| Norton Cancer Institute /ID# 248903 | Recruiting | Louisville | Kentucky | 40241-2832 | United States |
| START Midwest /ID# 248685 | Recruiting | Grand Rapids | Michigan | 49546-7062 | United States |
| M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200 | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399 | Recruiting | Omaha | Nebraska | 68130 | United States |
| Duke Cancer Institute /ID# 276267 | Recruiting | Durham | North Carolina | 27710 | United States |
| Carolina BioOncology Institute /ID# 232597 | Recruiting | Huntersville | North Carolina | 28078 | United States |
|
| NEXT Oncology Austin /ID# 243005 | Recruiting | Austin | Texas | 78705-1171 | United States |
| The University of Texas MD Anderson Cancer Center /ID# 270059 | Recruiting | Houston | Texas | 77030 | United States |
| Next Oncology Dallas /ID# 276254 | Recruiting | Irving | Texas | 75039 | United States |
| NEXT Oncology /ID# 243007 | Recruiting | San Antonio | Texas | 78229 | United States |
| South Texas Accelerated Research Therapeutics (START) /ID# 276268 | Recruiting | San Antonio | Texas | 78229 | United States |
| Start Mountain Region /ID# 276270 | Recruiting | West Valley City | Utah | 84119 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 232592 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Tom Baker Cancer Centre /ID# 276206 | Recruiting | Calgary | Alberta | T2N 4N2 | Canada |
| Princess Margaret Cancer Centre /ID# 276275 | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274 | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
| Shamir Medical Center /ID# 276238 | Recruiting | Beer Ya'akov | Central District | 70300 | Israel |
| Meir Medical Center /ID# 277327 | Recruiting | Kefar Sava | Central District | 4428164 | Israel |
| Rabin Medical Center. /ID# 250497 | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| The Chaim Sheba Medical Center /ID# 238332 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 276591 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus /ID# 238333 | Recruiting | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center /ID# 276244 | Recruiting | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 252287 | Recruiting | Jerusalem | 91120 | Israel |
| Aichi Cancer Center Hospital /ID# 250405 | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East /ID# 238840 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kobe University Hospital /ID# 250409 | Recruiting | Kobe | Hyōgo | 650-0017 | Japan |
| Kansai Medical University Hospital /ID# 276805 | Recruiting | Hirakata-shi | Osaka | 573-1191 | Japan |
| Shizuoka Cancer Center /ID# 250408 | Recruiting | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital /ID# 238372 | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
| Wakayama Medical University Hospital /ID# 276806 | Completed | Wakayama | Wakayama | 641-8510 | Japan |
| National Cancer Center /ID# 252290 | Recruiting | Goyang-si | Gyeonggido | 10408 | South Korea |
| CHA Bundang Medical Center /ID# 252291 | Recruiting | Seongnam | Gyeonggido | 13496 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 252288 | Recruiting | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Asan Medical Center /ID# 252289 | Recruiting | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867 | Recruiting | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Taipei Medical University Shuang Ho Hospital /ID# 252449 | Recruiting | New Taipei City | 23561 | Taiwan |
| National Cheng Kung University Hospital /ID# 252262 | Recruiting | Tainan | 704 | Taiwan |
| National Taiwan University Hospital /ID# 251894 | Recruiting | Taipei | 100 | Taiwan |
| Taipei Medical University Hospital /ID# 252450 | Recruiting | Taipei | 11031 | Taiwan |
| Tri-Service General Hospital /ID# 252263 | Recruiting | Taipei | 11490 | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| C537768 | Anophthalmia with pulmonary hypoplasia |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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