← Back to Search

Recombinant Fusion Protein

MT-5111 (experimental study drug) for Solid Cancers (MT-5111 Trial)

Phase 1

Waitlist Available

Research Sponsored by Molecular Templates, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 8, and day 15 in each 21-day cycle

Awards & highlights

MT-5111 Trial Summary

This trial will test a new protein drug in people with HER2-positive cancer. The drug will be given alone to see how well it works and what dose is safe.

MT-5111 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 8, and day 15 in each 21-day cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 8, and day 15 in each 21-day cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 8, and day 15 in each 21-day cycle for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

To evaluate tolerability and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

Secondary outcome measures

PK as measured by concentrations of free MT-5111 (Area Under the Curve [AUC])

PK as measured by concentrations of free MT-5111 (Maximum Plasma Concentration [Cmax])

PK as measured by concentrations of free MT-5111 (Time to reach maximum concentration after drug administration [Tmax])

+2 more

Other outcome measures

If warranted by the study results, to evaluate the exposure-response relationship for MT-5111

To correlate the pharmacodynamic markers of cancer under study (for breast cancer subjects using historic data, if available)

To correlate the pharmacodynamic markers of cancer under study relationship for MT-5111 using the PK, pharmacodynamics, safety, and tumor response variables.

+1 more

MT-5111 Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B- Dose ExpansionExperimental Treatment1 Intervention

Part B - Dose Expansion in previously treated HER2-positive breast, GEA and other HER2-positive solid cancers Part B will include 3 expansion groups: Group B1 (Breast Cancer) will begin enrolling while Part A is being conducted following the completion of Cohort 7 and Subsequent cohort of subjects in group B1 may enroll into higher doses that are tolerated in Part A. Group B2 (GEA) and Group B3 (Other HER-2 positive solid cancer groups) will begin enrollment after the MTD or RP2D is determined in Part A. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

Group II: Part A- Dose EscalationExperimental Treatment1 Intervention

Part A- Dose Escalation in patients with previously treated advanced HER2-positive solid tumors. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Molecular Templates, Inc.Lead Sponsor

9 Previous Clinical Trials

407 Total Patients Enrolled

Frequently Asked Questions

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

In which geographical regions is this medical experiment being conducted?

"The research team is conducting this clinical trial from Northwestern University in Chicago, IL, University of Michigan in Ann Arbor, MI and BRCR Medical Center in Plantation, FL as well as additional sites across 21 other geographic areas."

Answered by AI

What is the capacity for enrollment in this trial?

"This trial necessitates the recruitment of 178 participants that match its defined inclusion criteria. Two sites for potential enrolment are Northwestern University in Chicago, IL and University of Michigan located in Ann Arbor, MI."

Answered by AI

What is the FDA status of MT-5111?

"MT-5111, an experimental drug, has only been tested on a limited scale and thus scored 1 in terms of safety."

Answered by AI

What are the core aims of this medical research?

"This 21-day trial seeks to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), and evaluate both pharmacokinetics as measured by MT-5111 concentrations, Tmax values, Cmax levels, and immunogenicity."

Answered by AI

Are there any openings for individuals to join the research study?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is currently enrolling patients who were first invited in November 2019 and was last updated July 1st 2022. The study requires 178 participants from 21 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of MT-5111 in HER2-positive Solid Tumors

2019. "Study of MT-5111 in HER2-positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04029922.