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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial studies safety and effectiveness of a new drug in treating advanced cancer that hasn't responded to traditional treatments. It will find the best dose and test for safety and activity.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Occurrence of treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Objective Response Rate (ORR)

+1 more

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 / 4Eligibility 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.

Current trends and future directions in the genetic therapy of human neoplastic disease.Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.New therapeutic strategies for lung cancer: biology and molecular biology come of age.

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Who is running the clinical trial?

MBrace TherapeuticsLead Sponsor

~57 spots leftby Jul 2025

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