What side effects are associated with this type of intervention?

Common cancer treatments, including chemotherapy and targeted therapies, often lead to a range of side effects. Chemotherapy can cause alopecia, nausea, fatigue, and peripheral neuropathy. Targeted therapies, such as PI3K inhibitors, may result in hyperglycemia, decreased appetite, and diarrhea. Scalp cooling used to prevent chemotherapy-induced alopecia can cause headaches, scalp pain, and a sensation of cold. Overall, while these treatments can be effective, they are associated with various mild to moderate adverse events that need to be managed.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced metastatic solid tumors, including immunotherapies and targeted therapies. Notable approvals include checkpoint inhibitors like nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Additionally, targeted therapies such as dabrafenib and trametinib, which inhibit BRAF mutations, have been approved for specific cancer types. These treatments have shown efficacy in various cancers, providing new options for patients with advanced disease.

What other types of research exist?

Promising novel alternatives to MBRC-101 for cancer patients in 2024 include: <ol> <li>Selpercatinib and Pralsetinib: Selective RET inhibitors for RET-mutated medullary thyroid cancer.</li> <li>Lutetium-177-PSMA-617: A radioligand therapy for metastatic castration-resistant prostate cancer.</li> <li>Pembrolizumab and Dostarlimab: Immune checkpoint inhibitors for metastatic castration-resistant prostate cancer with dMMR or high TMB.</li> <li>Infigratinib and Futibatinib: FGFR-selective tyrosine kinase inhibitors for advanced cholangiocarcinoma with FGFR2 fusions/rearrangements.</li> <li>Nivolumab plus Ipilimumab and Cabozantinib: Combination therapy for advanced renal cell carcinoma.</li> </ol>

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Monoclonal Antibodies

Antibody-Drug Conjugate for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by MBrace Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard of care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines.

For Cohort C (basket cohort) of Dose Expansion (Phase 1b), patients must have tumor tissue positive (IHC H-score ≥ 1) for EphA5 expression (as measured by a Sponsor-designated central laboratory using archival or fresh primary or metastatic invasive tumor tissue submitted for analysis). Tumor biopsies involving significant risk procedure should not be performed to assess eligibility. Confirmation of EphA5 expression in tumor tissue is required prior to patient enrollment in Cohort C (basket cohort) only.

Must not have

Preexisting sensory neuropathy Grade ≥ 2.

Preexisting motor neuropathy Grade ≥ 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing MBRC-101, a new drug, in patients with advanced cancers that haven't improved with other treatments. It aims to find the best dose and check its safety and effectiveness. The study will also observe how the drug behaves in the body and if it causes any immune reactions.

Who is the study for?

Adults with advanced solid tumors that no longer respond to standard treatments can join this trial. They must have a life expectancy of at least 3 months, be able to give informed consent, and agree to use effective contraception. Specific criteria apply for different phases and cohorts regarding tumor type and expression of a protein called EphA5.

What is being tested?

MBRC-101, an antibody-drug conjugate, is being tested in patients with refractory cancer. The study has two parts: Phase 1 determines the safest dose levels; Phase 1b assesses safety further and looks for signs of effectiveness. Participants' reactions to the drug are closely monitored over time.

What are the potential side effects?

As MBRC-101 is new, potential side effects aren't fully known but may include typical reactions seen with other cancer drugs like fatigue, nausea, blood count changes or allergic responses. Close monitoring will help identify any adverse effects participants might experience.

Eligibility Criteria

Inclusion Criteria

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

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I have a cancer diagnosis with no standard treatment options left, or I am ineligible or refuse them.

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My tumor tested positive for EphA5 expression.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

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I do not have moderate or severe numbness in my hands or feet.

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I have moderate to severe muscle weakness.

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I do not have uncontrolled brain metastases.

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I haven't received any cancer treatment in the last 14 days, except for hormone therapy for prostate or early-stage breast cancer.

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I haven't taken strong CYP3A or P-gp inhibitors in the last 14 days.

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I have not had blood clots or bleeding issues in the last 14 days.

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I've had a stroke, heart attack, or severe heart symptoms in the last 6 months.

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I am not on high doses of steroids (40 mg/day or more) for immunotherapy side effects.

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I am able to understand and follow the study's procedures.

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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period

Occurrence of treatment-emergent adverse events (TEAEs)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

Objective Response Rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b ExpansionExperimental Treatment1 Intervention

Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antibody-Drug Conjugate

2022

N/A

~24620

0 / 14Eligibility 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

Common cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy damages the DNA of cancer cells, leading to cell death. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Targeted therapies focus on specific molecular targets involved in cancer growth and progression, such as tyrosine kinase inhibitors. Understanding these mechanisms is crucial for cancer patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes. Investigational treatments like MBRC-101, though not fully detailed, likely aim to exploit novel mechanisms to provide additional therapeutic options.

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