Magrolimab for Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
UC San Diego Moores Cancer Center, La Jolla, CA
Cancer+1 More
Magrolimab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug called magrolimab can be safely combined with a chemotherapy drug called docetaxel.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Magrolimab will improve 3 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 6 months.

Year 3
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
Up to 3 years
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)
Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)
Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)
Up to 6 months
Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)
Year 3
Percentage of Participants who Developed Anti-Magrolimab Antibodies
Serum Concentration for Magrolimab

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)

This trial requires 128 total participants across 4 different treatment groups

This trial involves 4 different treatments. Magrolimab is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

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.
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.
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.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Magrolimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

UC San Diego Moores Cancer Center - La Jolla, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adequate blood counts
Adequate liver function
You have adequate renal function. show original
You have a positive blood cross-match. show original
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
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.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cancer?

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The most common symptoms of cancer are changes in mood, fatigue and breathlessness.\n\nIt’s hard to know if your partner was actually sick from illness-related symptoms, which is

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What is cancer?

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It is important to recognise and understand that cancer is not just a disease of the bones, blood vessels or glands or any other part of a body but is an invisible disease of the cells and tissues that compose the body.

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What are common treatments for cancer?

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Despite common practices, patients with cancer still experience a wide variety of symptoms in different sites and organs. The treatment of cancer is extremely wide, and treatment plans are varied depending on the particular type of cancer and the age and circumstances of the patient. There is no single optimal treatment for cancer.

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How many people get cancer a year in the United States?

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About 3.2 million new cancer cases are expected to occur during 2002. Breast cancer is currently the leading cancer in women and leukemia in men and adolescents.

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What causes cancer?

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The cause of most cancers are related to environmental factors, but even when the exact cause is known, it is not always possible to prevent cancer. Cancer is often due to a combination of inheritance, environmental factors, and a predisposition.\n

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Can cancer be cured?

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A variety of cancers are curable, with some patients cured and others not. The cancer remains a problem, but in many cases the treatment provides significant symptom control and longer survival rates. Curing the cancer will not stop the disease from affecting the heart.

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Who should consider clinical trials for cancer?

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Clinical trials offer a promising path for the development of effective cancer therapies, although this option should be considered only after having made decisions about standard of care treatment for other patients who do not have access to clinical trials at the time of enrollment. Clinicians should consider clinical trials when there is a reasonable probability, based on data from their patients or clinical data regarding the likelihood of an unmeasurable improvement or a clinically relevant improvement, that a therapy will achieve this improvement. Patients who have a medical contraindication for trial participation are an excellent example of this recommendation. Physicians who decide not to recommend trials to their patients may consider a statement about clinical trial participation and the potential benefits and risks of such participation for those patients who are interested in participating.

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Have there been other clinical trials involving magrolimab?

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Magrolimab has no indication for patients with advanced solid tumors (in particular sarcomas and hematological malignancies) or patients with metastatic solid tumors. Clinical trial phase I (pancreatic cancer, renal cell carcinoma, colon carcinoma, and ovarian carcinoma), phase II (glioblastoma and ovarian carcinoma), and phase III (renal cell carcinoma). No other indications have been evaluated.

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How serious can cancer be?

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The seriousness of cancer is undeniable! If it is a progressive disease, life expectancy is less than that of even the most severe acute disorders in the United States. When it spreads to distant organs, its serious effects are also readily demonstrable. Whether the disease will become chronic, recrudescent, or even chronic and recrudescent in a second, third, or subsequent lifetime is just as certain as the prognosis for any other disease. When I think of the seriousness of cancer, at least in a general sense, I think of my own mother’s dying on November 20, 1978.

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Have there been any new discoveries for treating cancer?

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It was an important step to bring together all advances in treating cancer for the purpose of making a breakthrough and eliminating the disease. Many of the people suffering from the disease are being cured successfully by the same old cancer drugs and treatment methods. If this is the way it has to go then change in this field is going to be necessary for future people to fight off this dreaded disease. There were also many great advances made on the study of the human genome of the cancer patient.

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Is magrolimab safe for people?

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Magrolimab appears to be safe in combination with chemotherapy, radiotherapy and targeted agents (EGFR, BRAF) in people with advanced non small cell lung cancer. It does not appear safe in combination with radiotherapy or chemotherapy for people with metastatic breast or ovarian cancer. Magrolimab was generally well tolerated, with most patients reporting an improvement in their quality of life while continuing their treatment.

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Does cancer run in families?

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Results from a recent clinical trial, which assessed the presence/absence of a family history of cancer at varying stages in family history, a family history was found in 31.9%, i. e., more than twice as likely as in the general population. The family history was present at early infancy more often in this population of Caucasian families. Results from a recent clinical trial are consistent with an ersatz familial history model.

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