Study of Magrolimab in Patients With Solid Tumors (ELEVATELung&UC)
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| ClinicalTrials.gov Identifier: NCT04827576 |
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Recruitment Status :
Recruiting
First Posted : April 1, 2021
Last Update Posted : May 6, 2023
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in patients with solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumor | Drug: Magrolimab Drug: Docetaxel | Phase 2 |
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:
- Phase 2 Cohort 1: a cohort of participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC) (Phase 2 Cohort 1a), metastatic urothelial cancer (mUC) (Phase 2 Cohort 1b), and metastatic small cell lung cancer (mSCLC) (Phase 2 Cohort 1c).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 116 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors |
| Actual Study Start Date : | October 1, 2021 |
| Estimated Primary Completion Date : | August 2024 |
| Estimated Study Completion Date : | March 2025 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
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Experimental: Safety Run-in Cohort 1, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel)
Participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), metastatic small cell lung cancer (mSCLC)) will receive an escalating dose of magrolimab and docetaxel.
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Drug: Magrolimab
Administered intravenously
Other Name: GS-4721 Drug: Docetaxel Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere® |
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Experimental: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
Participants with mNSCLC will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety Run-in Cohort 1 and docetaxel.
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Drug: Magrolimab
Administered intravenously
Other Name: GS-4721 Drug: Docetaxel Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere® |
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Experimental: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
Participants with mUC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
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Drug: Magrolimab
Administered intravenously
Other Name: GS-4721 Drug: Docetaxel Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere® |
|
Experimental: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
Participants with mSCLC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
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Drug: Magrolimab
Administered intravenously
Other Name: GS-4721 Drug: Docetaxel Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere® |
Primary Outcome Measures :
- Percentage of Participants Experiencing Adverse Events According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: First dose date up to 3 years ]
- Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0 [ Time Frame: First dose date up to 3 years ]
- Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 6 months ]ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment.
Secondary Outcome Measures :
- Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]PFS is defined as the time from the date of dose initiation until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first.
- Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]DOR is defined as time from first documentation of CR or PR to the earliest date of documented disease progression, per RECIST version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment.
- Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]OS is defined as time from date of dose initiation to death from any cause.
- Serum Concentration for Magrolimab [ Time Frame: Up to end of treatment (approximately 3 years) ]
- Percentage of Participants who Developed Anti-Magrolimab Antibodies [ Time Frame: Up to end of treatment (approximately 3 years) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Adequate blood counts
- Adequate renal function
- Adequate liver function
- Pretreatment blood cross-match completed
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- Measurable disease according to RECIST version 1.1
Cohort-Specific Inclusion Criteria:
- Safety Run-in Cohort 1: Individuals with metastatic advanced solid tumors who have had at least 1 prior line of systemic anticancer therapy (metastatic non-small cell lung cancer (mNSCLC) and metastatic small cell lung cancer (mSCLC)) in a locally advanced/metastatic setting, or 2 prior lines of systemic anticancer therapy (metastatic urothelial cancer(mUC)) in a locally advanced/metastatic setting, and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting.
- Phase 2 Cohort 1a (mNSCLC): Individuals with NSCLC who have had treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Individuals who were treated for epidermal growth factor receptor (EGFR), c-ros oncogene 1 (ROS1), anaplastic lymphoma kinase (ALK), neurotrophic tyrosine kinase (NTRK), or mesenchymal-epithelial transition (MET) exon 14 genomic alterations are excluded.
- Phase 2 Cohort 1b (mUC): Individuals with UC who have had prior treatment with systemic chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are required and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.
- Phase 2 Cohort 1c (mSCLC): Individuals with SCLC who have had prior treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.
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 CD47 or signal regulatory protein alpha-targeting agents
- Current participation in another interventional clinical trial
- 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
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Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
- Note: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappaB ligand (RANKL) inhibitors are not criteria for exclusion.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827576
Contacts
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Locations
Show 49 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT04827576 |
| Other Study ID Numbers: |
GS-US-548-5918 2020-005265-14 ( EudraCT Number ) |
| First Posted: | April 1, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Docetaxel Magrolimab Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |