What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those similar to magrolimab (an anti-CD47 monoclonal antibody) and docetaxel (a chemotherapy agent), include infusion-related reactions, fatigue, immune-related adverse events (such as colitis or pneumonitis), myelosuppression (neutropenia, anemia, thrombocytopenia), alopecia, mucositis, peripheral neuropathy, and gastrointestinal symptoms (nausea, vomiting, diarrhea). Combining these treatments may increase the likelihood of these side effects, requiring careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve monoclonal antibodies and chemotherapeutic agents. For instance, Pembrolizumab (Keytruda), a monoclonal antibody targeting PD-1, has been approved for various solid tumors, including melanoma and non-small cell lung cancer. Similarly, Bevacizumab (Avastin), an anti-VEGF monoclonal antibody, is approved for colorectal cancer, non-small cell lung cancer, and glioblastoma, among others. Docetaxel, a chemotherapeutic agent, is approved for use in breast cancer, non-small cell lung cancer, prostate cancer, and gastric adenocarcinoma. These approvals highlight the FDA's recognition of the efficacy of combining monoclonal antibodies with chemotherapy in treating solid tumors.

What other types of research exist?

Promising alternatives for solid tumor treatment in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor) in combination with Lenvatinib, which has shown efficacy in endometrial cancer. 2) Atezolizumab plus Bevacizumab, which has demonstrated effectiveness in renal cell carcinoma. 3) Nivolumab and Ipilimumab combination therapy, which has been effective in various cancers including renal cell carcinoma and mesothelioma.

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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

Must not have

Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.

Known inherited or acquired bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of magrolimab and docetaxel in patients with certain types of advanced cancers. Magrolimab helps the immune system fight cancer, while docetaxel kills cancer cells. The study aims to find out if this combination is safe and effective for patients whose cancers have spread and may not respond to standard treatments. Docetaxel has been widely used in various cancer treatments, including prostate and breast cancer, often in combination with other agents to improve efficacy and reduce side effects.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had any cancer treatment including chemotherapy or immunotherapy in the last 4 weeks.

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I have a known bleeding disorder.

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I am currently breastfeeding.

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I have been treated with drugs targeting CD47 or signal regulatory protein alpha.

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I haven't had hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.

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I do not have severe heart issues, uncontrolled diabetes, or serious infections.

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I have an active or chronic hepatitis B or C infection, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)

Secondary study objectives

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)

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Abdominal pain

33%

Infusion related reaction

33%

Malignant neoplasm progression

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Lactic acidosis

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

33%

Nausea

33%

Aspartate aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Blood lactate dehydrogenase increased

33%

Mental disorder

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab Priming Dose Only

Magrolimab 45 mg/kg

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2022

Completed Phase 2

~220

Docetaxel

1995

Completed Phase 4

~6550

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Magrolimab, an anti-CD47 monoclonal antibody, blocks the CD47 protein on cancer cells, promoting their phagocytosis by macrophages. Docetaxel, a chemotherapy agent, stabilizes microtubules, preventing cell division and leading to apoptosis. These mechanisms are important for solid tumor patients as they address both immune evasion and rapid cell proliferation, potentially improving treatment efficacy.

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