Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005265-14 | EudraCT Number |
Not provided
Not provided
Sponsor decision to terminate study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in participants with solid tumors.
This study will consist of a Safety Run-in Cohort 1 (magrolimab + docetaxel combination). After completion of the Safety Run-in Cohort 1, Phase 2 Cohort 1 will occur as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Experimental | Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) will receive 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days. |
|
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Experimental | Participants with mNSCLC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days. |
|
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Experimental | Participants with mUC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
|
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magrolimab | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. | First dose date up to 113 weeks plus 30 days |
| Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off. | First dose date up to 113 weeks plus 30 days |
| Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded-off. | Up to 90 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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 one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis. |
Not provided
Key Inclusion Criteria:
Cohort-Specific Inclusion Criteria:
Note: Maintenance therapies are not counted as separate lines of therapy.
Key Exclusion Criteria:
Positive serum pregnancy test.
Breastfeeding female.
Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha-targeting agents.
Current participation in another interventional clinical study.
Known inherited or acquired bleeding disorders.
Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.
Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and who are in complete remission for over 3 years.
Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Treatment Centers of America | Goodyear | Arizona | 85338 | United States | ||
| UC San Diego Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Van Burren N, U'Ren L, Song K, Liu Y, Correa P, Tang S, et al. Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE Lung and UC, a Phase 2 multicohort study [Abstract]. J Immunother Cancer. 2024;12. doi:10.1136/jitc- 2024-SITC2024.0184. | ||
| Background | Van Burren N, U'Ren L, Song K, Liu Y, Correa P, Tang S, et al. Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE Lung and UC, a Phase 2 multicohort study. Poster presented at: 2024 Society for Immunotherapy of Cancer (SITC); 2024 Nov 6-10; Houston, TX, USA. | ||
| Background | Juan-Vidal O, Fang B, Paz-Ares LG, Ortega Granado AL, Vicuna BD, Bodnar L, et al. Magrolimab + docetaxel in previously treated patients with metastatic non-small cell lung cancer [Abstract]. J Immunother Cancer. 2024;12. doi:10.1136/jitc-2024-SITC2024.0604. | ||
| Background | Juan-Vidal O, Fang B, Paz-Ares LG, Ortega Granado AL, Vicuna BD, Bodnar L, et al. Magrolimab + docetaxel in previously treated patients with metastatic non-small cell lung cancer. Poster presented at: 2024 Society for Immunotherapy of Cancer (SITC); 2024 Nov 6-10; Houston, TX, USA. | ||
| Background | Vaishampayan UN, Puri S, Kummar S, Perez JM, Italiano A, Shao J, et al. A Phase 2 multiarm study of magrolimab in combination with docetaxel in patients with locally advanced or metastatic solid tumors: ELEVATE-Lung and UC. J Clin Oncol. 2023;41(16_suppl):TPS9142-TPS9142. | ||
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
159 participants were screened.
Participants were enrolled at study sites in Spain, Poland, France, United States, and the United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2023 | Mar 24, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants with mSCLC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.
|
|
| Docetaxel | Drug | Administered intravenously |
|
|
| Up to 117 Weeks |
| Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis. | Up to 117 Weeks |
| Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in outcome measure analysis. | Up to 117 Weeks |
| Serum Concentration of Magrolimab | Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose |
| Percentage of Participants Who Developed Anti-Magrolimab Antibodies | Up to 113 Weeks |
| La Jolla |
| California |
| 92093 |
| United States |
| Providence Saint John's Health Center | Santa Monica | California | 90404 | United States |
| St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| University of Miami | Deerfield Beach | Florida | 33064 | United States |
| Tallahassee Memorial Healthcare Cancer Center | Tallahassee | Florida | 32308 | United States |
| University Center and Blood Center,LLC. | Athens | Georgia | 30607 | United States |
| Southeastern regional Medical Center | Newnan | Georgia | 30265 | United States |
| Saint Alphonsus Cancer Institute Caldwell | Caldwell | Idaho | 83605 | United States |
| Orchard Healthcare Research Inc | Skokie | Illinois | 60077 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Virginia Piper Cancer Center (Alliant Health) | Saint Paul | Minnesota | 55102 | United States |
| Comprehensive Cancer Centers of Nevada- Twain Office | Las Vegas | Nevada | 89169 | United States |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Charleston Oncology | Charleston | South Carolina | 29414 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| MD Anderson Cancer Center | Dallas | Texas | 77030 | United States |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | United States |
| Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment) | Spokane | Washington | 99208 | United States |
| Institut Bergonie | Bordeaux | 33000 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Centre Hospitalier Regional Universitaire de Lille | Lille | 59037 | France |
| Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer | Lyon | 69373 | France |
| Hopital Nord AP-HM | Marseille | 13005 | France |
| Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est | Nice | 6189 | France |
| Hôpital de la Pitié Salpétrière | Paris | 75013 | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69310 | France |
| Institut de Cancérologie de l'Ouest (ICO) - Saint-Herblain | Saint-Herblain | France |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | 85-796 | Poland |
| Instytut Centrum Zdrowia Matki Polki | Lodz | 93-513 | Poland |
| Wojewodzki Szpital Specjalistyczny w Siedlcach | Siedlce | 08-110 | Poland |
| Instituto de Investigacion Oncologica Vall de Hebron | Barcelona | 08035 | Spain |
| Hospital del Mar | Barcelona | 8003 | Spain |
| Hospital Quironsalud Barcelona | Barcelona | 8023 | Spain |
| Hospital De La Santa Creu I Sant Pau | Barcelona | 8041 | Spain |
| Hospital Universitario de Jaen | Jaén | 23007 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Background |
| Subbiah V, Vaishampayan UN, Puri S, Lin L, Chao M, Ramsingh G, et al. A Phase 2, multiarm study of anti-CD47 antibody, magrolimab, in combination with docetaxel in patients with locally advanced or metastatic solid tumors. J Clin Oncol. 2022;40(6_suppl):TPS584-TPS584. |
| FG001 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) |
Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days. |
| FG002 | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| FG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent to treat analysis set included all enrolled participants who took at least 1 dose of any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days. |
| BG001 | Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days. |
| BG002 | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| BG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
| BG004 | Total~(N=106) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. | Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set included all participants who took at least 1 dose of any study drug. | Posted | Number | percentage of participants | First dose date up to 113 weeks plus 30 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to 113 weeks plus 30 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded-off. | Participants in the modified intent to treat analysis set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 90 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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 one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. | Posted | Median | 95% Confidence Interval | months | Up to 117 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis. | Participants in the modified Intent-to-Treat Analysis Set who achieved CR or PR were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. | Posted | Median | 95% Confidence Interval | months | Up to 117 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in outcome measure analysis. | Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. | Posted | Median | 95% Confidence Interval | months | Up to 117 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Magrolimab | The participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set included all participants who received any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of magrolimab. Here 'N' is defined as participants with available data at the given timepoint. | Posted | Mean | Standard Deviation | μg/mL | Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set includes all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result. | Posted | Number | percentage of participants | Up to 113 Weeks |
|
All-cause mortality: Up to 117 weeks; Adverse events: Up to 113 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days. | 6 | 9 | 5 | 9 | 9 | 9 |
| EG001 | Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days. | 17 | 29 | 16 | 29 | 29 | 29 |
| EG002 | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. | 18 | 26 | 12 | 26 | 26 | 26 |
| EG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. | 37 | 42 | 18 | 42 | 41 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vascular device occlusion | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral small vessel ischaemic disease | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2024 | Mar 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| France |
|
| Poland |
|
| United Kingdom |
|
| OG002 | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| OG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
| OG002 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| OG002 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
| OG002 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
| OG002 | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| OG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. |
| OG003 | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|