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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

Duration of Response (DOR)

Objective Response Rate (ORR)

Progression-Free Survival (PFS)

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

Find a Location

Who is running the clinical trial?

MBrace TherapeuticsLead Sponsor

Frequently Asked Questions

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

Has the FDA authorized Phase 1 Dose Escalation?

"Because of the limited clinical data surrounding Phase 1 Dose Escalation, our team at Power assigned it a safety rating of 1."

Answered by AI

How many locations within the United States are currently running this clinical experiment?

"This trial is enrolling patients in Austin, Irving and Fairfax as well as 4 other locations. To reduce the amount of travel necessary for your involvement it's important to select a clinic close by."

Answered by AI

Are there any vacancies available in this research endeavor?

"According to clinicaltrials.gov, this particular trial has been closed and is no longer recruiting patients. The research was posted on October 1st 2023 and the most recent update occurred on September 6th of the same year. However, there are currently 542 other trials that are still actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors

2023. "Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014658.