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Business Decision
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| CSPC Pharmaceutical Group Limited | INDUSTRY |
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This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EO-3021 Monotherapy | Experimental | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 monotherapy at various doses every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received one and no more than three lines of prior systemic therapy in the advanced metastatic setting will be randomized to one of two doses of EO-3021 dosed every 3 weeks to confirm RP2D. |
|
| EO-3021 in combination with ramucirumab | Experimental | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received only one prior systemic therapy in the advanced metastatic setting will be treated with EO-3021 in combination with ramucirumab every 3 weeks to confirm RP2D. |
|
| EO-3021 in combination with dostarlimab | Experimental | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have not received any prior systemic therapies in the advanced metastatic setting will be treated with EO-3021 in combination with dostarlimab every 3 weeks to confirm RP2D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EO-3021 | Drug | Anti-Claudin 18.2 antibody drug conjugate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) | |
| The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | The first 21-day treatment cycle for each patient enrolled in the Escalation Phase | |
| Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) | |
| Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose | |
| Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) | |
| The Estimate of Overall Response Rate (ORR) for the Efficacy Population. | Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1. |
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Key Inclusion Criteria:
Availability of tumor tissue for evaluation of biomarker
Patients enrolled to expansion must have tumors expressing CLDN 18.2 based on central prospective IHC testing.
Histologically and/or cytologically confirmed diagnosis of advanced metastatic gastric/GEJ adenocarcinoma not amenable to resection or radiation therapy with curative intent
•≥ 18 years of age
ECOG performance status (PS) 0 or 1 at Screening
Progressed on or after standard therapy, or are intolerable of available standard therapy, or there is no available standard therapy
In dose escalation, there is no limit on the number of prior lines of therapy.
In expansion, for EO-3021 monotherapy, at least 1 but no more than 3 prior lines of therapy in the advanced/metastatic setting is allowed
In expansion, for EO-3021 in combination with ramucirumab, only 1 prior line of therapy in the advanced/metastatic setting is allowed. Prior fluoropyrimidine and platinum-containing chemotherapy is required
In expansion, for EO-3021 in combination with dostarlimab, no prior systemic therapy in the advanced/metastatic setting is allowed.
Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
Adequate organ function
Life expectancy > 12 weeks
Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent
Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 6 months following study completion (or longer if required by local regulation)
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| City of Hope |
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| ID | Title | Description |
|---|---|---|
| FG000 | EO-3021 Monotherapy 1.0 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| FG001 | EO-3021 Monotherapy 2.0 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2024 | Jul 18, 2025 |
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| Ramucirumab (CYRAMZA®) | Drug | VEGFR2 inhibitor |
|
| Dostarlimab | Drug | anti-PD-1 antibody |
|
| Up to 24 months |
| Duarte |
| California |
| 91010 |
| United States |
| Yale - Smilow Cancer Hospital | New Haven | Connecticut | 06519 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Johns Hopkins University - Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Sarah Cannon Research Institute at Florida Cancer Specialists | Orlando | Florida | 32827 | United States |
| Henry Ford Cancer | Detroit | Michigan | 48202 | United States |
| START Midwest | Grand Rapids | Michigan | 49546 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Atrium Health/Wake Forest University | Charlotte | North Carolina | 28204 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UW Carbone Cancer Center - Cancer Connect | Madison | Wisconsin | 53792 | United States |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | 104-0045 | Japan |
| Samsung Medical Center | Seoul | South Korea |
| Yonsei University | Seoul | South Korea |
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| FG002 | EO-3021 Monotherapy 2.5 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| FG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| FG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| FG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EO-3021 Monotherapy 1.0 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| BG001 | EO-3021 Monotherapy 2.0 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| BG002 | EO-3021 Monotherapy 2.5 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| BG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| BG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| BG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | Posted | Count of Participants | Participants | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) |
|
|
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | Posted | Count of Participants | Participants | The first 21-day treatment cycle for each patient enrolled in the Escalation Phase |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | Posted | Count of Participants | Participants | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab | Posted | Count of Participants | Participants | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. | Posted | Count of Participants | Participants | From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Estimate of Overall Response Rate (ORR) for the Efficacy Population. | Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1. | The Efficacy Evaluable Population includes all patients who receive at least one dose of EO-3021, have baseline measurable disease and at least one post baseline imaging assessment. | Posted | Count of Participants | Participants | Up to 24 months |
|
1 year 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EO-3021 Monotherapy 1.0 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | EO-3021 Monotherapy 2.0 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate | 29 | 42 | 20 | 42 | 42 | 42 |
| EG002 | EO-3021 Monotherapy 2.5 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate | 19 | 34 | 15 | 34 | 34 | 34 |
| EG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate | 4 | 6 | 4 | 6 | 6 | 6 |
| EG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor | 0 | 2 | 0 | 2 | 2 | 2 |
| EG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Upper Gasterointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Biliary Tract Infection | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cerebral Infarction | Vascular disorders | Systematic Assessment |
| ||
| Completed Suicide | Psychiatric disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Duodenal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Failure to Thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired Gastric Temptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Jaundice Cholestatic | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Keratopathy | Eye disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Edema Peripheral | General disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Eye | Eye disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
| ||
| Weight Decreased | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infusion Related Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Elevation Oncology | +1-716-371-1125 | medinfo@elevationoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2025 | Jul 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| C000719628 | dostarlimab |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| OG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
|
|
| OG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| OG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
|
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| OG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| OG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
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| OG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| OG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody |
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| OG002 | EO-3021 Monotherapy 2.5 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion. EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG003 | EO-3021 Monotherapy 2.9 mg/kg | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate |
| OG004 | EO-3021 2.0 mg/kg in Combination With Ramucirumab | In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Ramucirumab (CYRAMZA®): VEGFR2 inhibitor |
| OG005 | EO-3021 2.0 mg/kg in Combination With Dostarlimab | "In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). EO-3021: Anti-Claudin 18.2 antibody drug conjugate Dostarlimab: anti-PD-1 antibody" |
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