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Anti-microtubule agent
Magrolimab + Docetaxel for Solid Tumors (ELEVATELung&UC Trial)
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ELEVATELung&UC Trial Summary
This trial is testing a combination of two drugs, magrolimab and docetaxel, to see if it is safe and effective in treating solid tumors.
Who is the study for?
This trial is for adults with certain advanced solid tumors who've had previous cancer treatments. They must be relatively healthy, not pregnant or breastfeeding, and agree to use birth control if necessary. People can't join if they have severe allergies to the drugs being tested, are in another clinical trial, need frequent blood transfusions, have serious health issues like heart failure or uncontrolled diabetes, active hepatitis B/C or HIV infections, recent hemolytic anemia or bleeding disorders.Check my eligibility
What is being tested?
The study tests Magrolimab combined with Docetaxel in patients with solid tumors. It aims to find out how safe and effective this combination is when given together. The participants will receive specific dosages of both drugs and their response to treatment will be monitored over time.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medication components, potential impact on liver and kidney function which will be closely monitored during the trial period. There may also be general side effects such as fatigue, nausea, hair loss from Docetaxel (a chemotherapy drug), and immune-related effects from Magrolimab.
ELEVATELung&UC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
ELEVATELung&UC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)
Percentage of Participants Experiencing Adverse Events According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0
Secondary outcome measures
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)
Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)
Percentage of Participants who Developed Anti-Magrolimab Antibodies
+2 moreSide effects data
From 2020 Phase 1 & 2 trial • 78 Patients • NCT0295378267%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Myalgia
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypokalaemia
11%
Dyspepsia
11%
Tumour pain
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
ELEVATELung&UC Trial Design
4Treatment groups
Experimental Treatment
Group I: Safety Run-in Cohort 1, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel)Experimental Treatment2 Interventions
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.
Group II: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)Experimental Treatment2 Interventions
Participants with mSCLC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
Group III: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)Experimental Treatment2 Interventions
Participants with mUC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
Group IV: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)Experimental Treatment2 Interventions
Participants with mNSCLC will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety Run-in Cohort 1 and docetaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magrolimab
2021
Completed Phase 2
~170
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,735 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,729 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment including chemotherapy or immunotherapy in the last 4 weeks.I have a known bleeding disorder.I am currently breastfeeding.I can take care of myself and am up and about more than half of my waking hours.I have advanced cancer and have received 1-3 treatments for it.I have SCLC, treated with 1-2 therapies before, but not with a taxane in the last year.My blood counts are within a healthy range.You have a known allergy or sensitivity to any of the study drugs or their ingredients.I have been treated with drugs targeting CD47 or signal regulatory protein alpha.I have no active cancer except for certain skin cancers, localized prostate cancer, or any cancer in remission for over 3 years.I have bladder cancer, treated with 2-3 prior therapies but not recently with a taxane.I have NSCLC and have had 1-2 treatments for it but not with taxane or targeted therapy for specific gene changes in the last year.I haven't had hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.I do not have severe heart issues, uncontrolled diabetes, or serious infections.I have brain involvement but it's stable and I haven't needed steroids for 4 weeks.My liver is working well.My kidneys are working well.I agree to use birth control as required by the study.I needed more than 2 blood transfusions in the last month.I have an active or chronic hepatitis B or C infection, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
- Group 2: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
- Group 3: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
- Group 4: Safety Run-in Cohort 1, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Magrolimab completed the process of FDA approval?
"Magrolimab's safety is based on data from Phase 2 trials, meaning that while there is no evidence of its efficacy yet, there are indications that it is safe."
Answered by AI
Is this trial only being done in one state or are multiple states participating?
"At the moment, there are 23 sites conducting this research. Some of these locations include Newnan, Athens and Charleston; however, there are 20 other cities where patients can be seen. To limit travel time and costs, please choose the location nearest you."
Answered by AI
Can you tell me if Magrolimab has been studied before in a clinical setting?
"To date, there are a total of 351 active studies investigating Magrolimab. Out of these studies, 135 have reached Phase 3 clinical trials with the remaining in lower phases of research. Many of the studies for Magrolimab are based out of Saint Louis, Missouri; however, there are 23567 locations running clinical trials for Magrolimab globally."
Answered by AI
How many individuals are part of this clinical trial in total?
"Yes, the information on clinicaltrials.gov points out that this clinical trial is presently recruiting participants. The clinical trial was originally posted on 10/1/2021 and was last updated on 11/4/2022. The study is recruiting for 116 patients across 23 sites."
Answered by AI
Are volunteers still being accepted for this clinical trial?
"Yes, the information available on clinicaltrials.gov indicates that this study is still recruiting patients. The trial was first posted on October 1st, 2021 and was most recently updated on November 4th, 2020. This study needs 116 participants in total, with 23 sites currently enrolling patients."
Answered by AI
To what purpose is Magrolimab most often put?
"Magrolimab is most popularly used to treat malignant neoplasms. However, it has also been shown to effectively manage symptoms for patients with advance directives, sarcoma, and esophageal neoplasms malignant."
Answered by AI
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