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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-2828 | Registry Identifier | ICTRP | |
| 2021-004423-32 | EudraCT Number |
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Sponsor decision, the decision is not related to any safety concern.
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This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).
Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tusamitamab ravtansine | Experimental | Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tusamitamab ravtansine | Drug | Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute Site Number : 8400004 | Buffalo | New York | 14263 | United States | ||
| Renovatio Clinical Site Number : 8400003 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 22 participants were enrolled in the study. Note: Reason for not completed = Reason for permanent full study intervention discontinuation.
The study was conducted at 35 investigational sites in 7 countries. A total of 30 participants were screened from 01-Jun-2022 to 01-Dec-2023 of which 8 were screen failures due to not meeting eligibility criteria. The study was terminated as per Sponsor decision and not related to any safety concern.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2) | Participants received tusamitamab ravtansine 100 mg/m^2 via intravenous (IV) infusion every 2 weeks (Q2W) until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment. |
| 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 27, 2021 | Mar 5, 2025 |
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| From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks |
| Progression-Free Survival (PFS) | The PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first as per RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
| Disease Control Rate (DCR) | The DCR was defined as the percentage of participants who achieved confirmed CR, PR or stable disease (SD) as BOR as per RECIST v1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on the study. | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
| Duration of Response (DOR) | The DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
| El Paso |
| Texas |
| 79915 |
| United States |
| Investigational Site Number : 0560003 | Edegem | 2650 | Belgium |
| Investigational Site Number : 0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number : 0560002 | Liège | 4000 | Belgium |
| Investigational Site Number : 2500003 | Bordeaux | 33076 | France |
| Investigational Site Number : 2500001 | Créteil | 94010 | France |
| Investigational Site Number : 2500007 | Marseille | 13015 | France |
| Investigational Site Number : 2500005 | Montpellier | 34295 | France |
| Investigational Site Number : 2500002 | Rennes | 35033 | France |
| Investigational Site Number : 2500006 | Saint-Herblain | 44800 | France |
| Investigational Site Number : 2500008 | Saint-Mandé | 94160 | France |
| Investigational Site Number : 2500009 | Villejuif | 94800 | France |
| Investigational Site Number : 3800003 | Ravenna | Emilia-Romagna | 48121 | Italy |
| Investigational Site Number : 3800004 | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Investigational Site Number : 3800001 | Rozzano | Lombardy | 20089 | Italy |
| Investigational Site Number : 3800002 | Milan | 20133 | Italy |
| Investigational Site Number : 3920002 | Nagoya | Aichi-ken | 460-0001 | Japan |
| Investigational Site Number : 3920001 | Sapporo | Hokkaido | 003-0804 | Japan |
| Investigational Site Number : 3920005 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Investigational Site Number : 3920003 | Sunto Gun | Shizuoka | 411-8777 | Japan |
| Investigational Site Number : 7240004 | Barcelona | Barcelona [Barcelona] | 08028 | Spain |
| Investigational Site Number : 7240006 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number : 7240001 | L'Hospitalet de Llobregat | Barcelona [Barcelona] | 08908 | Spain |
| Investigational Site Number : 7240008 | Majadahonda | Madrid | 28222 | Spain |
| Investigational Site Number : 7240002 | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Investigational Site Number : 7240009 | Madrid / Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number : 7240003 | Málaga | 29010 | Spain |
| Investigational Site Number : 7240005 | Seville | 41013 | Spain |
| Investigational Site Number : 7240007 | Valencia | 46026 | Spain |
| Investigational Site Number : 7920002 | Adana | 01120 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Ankara | 06800 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Istanbul | 34300 | Turkey (Türkiye) |
| Investigational Site Number : 7920004 | Istanbul | 34722 | Turkey (Türkiye) |
| Investigational Site Number : 7920001 | Malatya | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tusamitamab Ravtansine 100 mg/m^2 | Participants received tusamitamab ravtansine 100 mg/m^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Objective Response Rate (ORR) | The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period. | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Posted | Count of Participants | Participants | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks |
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| Secondary | Progression-Free Survival (PFS) | The PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first as per RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
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| Secondary | Disease Control Rate (DCR) | The DCR was defined as the percentage of participants who achieved confirmed CR, PR or stable disease (SD) as BOR as per RECIST v1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on the study. | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
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| Secondary | Duration of Response (DOR) | The DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only responders (those participants with confirmed CR or PR) were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks |
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Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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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 | Tusamitamab Ravtansine 100 mg/m^2 | Participants received tusamitamab ravtansine 100 mg/m^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment. | 13 | 22 | 7 | 22 | 18 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
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| Right Ventricular Failure | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Pain | General disorders | MedDra 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
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| Keratitis | Eye disorders | MedDra 27.1 | Systematic Assessment |
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| Keratopathy | Eye disorders | MedDra 27.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDra 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDra 27.1 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDra 27.1 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDra 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
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The study was terminated as per Sponsor decision and not related to any safety concern.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | #6 | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2024 | Mar 5, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000720449 | tusamitamab ravtansine |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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