MT-5111 (experimental study drug) for Solid Cancers

Northwestern University, Chicago, IL
Solid CancersMT-5111 (experimental study drug) - Drug
Eligibility
18+
All Sexes

Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Day 1, Day 8, and Day 15 in Each 21-Day cycle

21 day cycle
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)
Month 24
To evaluate overall Survival
Day 15
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])
Screening (baseline)
To correlate the pharmacodynamic markers of cancer under study (for breast cancer subjects using historic data, if available)
Day 21
To evaluate the immunogenicity of MT-5111
Week 6
If warranted by the study results, to evaluate the exposure-response relationship for MT-5111
To correlate the pharmacodynamic markers of cancer under study relationship for MT-5111 using the PK, pharmacodynamics, safety, and tumor response variables.
Week 6
To evaluate the tumor response to MT-5111

Trial Safety

Phase-Based Safety

1 of 3

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CB-03-10
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Arm 1- Dose Expansion
1 of 4
Arm 1- Dose Escalation
1 of 4
Part A- Dose Escalation
1 of 4
Part B- Dose Expansion
1 of 4

Experimental Treatment

178 Total Participants · 4 Treatment Groups

Primary Treatment: MT-5111 (experimental study drug) · No Placebo Group · Phase 1

Arm 1- Dose Expansion
Drug
Experimental Group · 1 Intervention: MT-5111 (experimental study drug) · Intervention Types: Drug
Arm 1- Dose Escalation
Drug
Experimental Group · 1 Intervention: MT-5111 (experimental study drug) · Intervention Types: Drug
Part A- Dose Escalation
Drug
Experimental Group · 1 Intervention: MT-5111 (experimental study drug) · Intervention Types: Drug
Part B- Dose Expansion
Drug
Experimental Group · 1 Intervention: MT-5111 (experimental study drug) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 8, and day 15 in each 21-day cycle

Who is running the clinical trial?

Molecular Templates, Inc.Lead Sponsor
8 Previous Clinical Trials
337 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried other treatments before, but they didn't work or caused side effects that you couldn't tolerate.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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