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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005589-16 | EudraCT Number | ||
| 2024-511116-25-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Q3W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. |
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| Dose Escalation Q4W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. |
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| Dose Escalation Q6W Cohort | Experimental | Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. |
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| Dose Expansion Cohort 1 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. |
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| Dose Expansion Cohort 2 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB308 | Drug | Administered intravenously (IV) as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Adverse Events | From first study treatment administration until up to 90 days after the last dose (Approximately 1 year) | |
| Percentage of participants who experience a Dose Limiting Toxicity | From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of AB308 | Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months) | |
| Serum concentration of zimberelimab |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles | California | 90095 | United States | ||
| Mayo Clinic Jacksonville - PPDS |
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| Label | URL |
|---|---|
| ARC-12 - Public website | View source |
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Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
For more information, please visit our website.
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| Dose Expansion Cohort 3 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. |
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| Dose Expansion Cohort 4 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. |
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| Dose Expansion Cohort 5 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. |
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| Zimberelimab | Drug | Administered IV as specified in the treatment arm |
|
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| Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months) |
| Percentage of participants with anti-drug antibodies to AB308 | Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months) |
| Percentage of participants with anti-drug antibodies to zimberelimab | Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months) |
| Percentage of participants with Objective Response | From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years) |
| Duration of Response | From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years) |
| Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months | From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Goshen Health System | Goshen | Indiana | 46526 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Norton Cancer Insititute-Downtown | Louisville | Kentucky | 40202 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Columbia University Medical Center | New York | New York | 10032-3729 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15240 | United States |
| Tennessee Onocology - Nashville | Nashville | Tennessee | 37205 | United States |
| START South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| START South Texas Accelerated Research Therapeutics - Mountain Region | West Valley City | Utah | 84119 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22033-1712 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Specjalistyczna Praktyka Lekarska Slawomir Mandziuk | Lubin | Poland |
| Med-Polonia Sp. z o.o. | Poznan | Poland |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Clínica Universidad de Navarra - Madrid | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| START MADRID Hospital Unviersitario Fundacion Jimenez Diaz | Madrid | Spain |
| Clínica Universidad de Navarra | Pamplona | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D002583 | Uterine Cervical Neoplasms |
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| 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 |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D016393 | Lymphoma, B-Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
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