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PD-L1 Inhibitor

MT-6402 for Solid Cancers

Phase 1
Recruiting
Research Sponsored by Molecular Templates, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of reproductive potential must have a negative highly sensitive pregnancy test within 72 hours before the start of treatment.
Arm 1: Histologically confirmed recurrent or metastatic NSCLC not amenable to standard treatment, or standard treatment is not available, or in the Investigator's opinion the standard treatment would not be in the subject's best interest. NOTE: subjects with driver mutations are only eligible if they have received all appropriate targeted therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years (parts 1 and 2)
Awards & highlights

Study Summary

This trial is for a new cancer treatment called MT-6402. It will test how well it works and what side effects it has in people with advanced solid cancer that is positive for PD-L1.

Who is the study for?
Adults with advanced solid cancers expressing PD-L1, who have measurable disease and are not suitable for standard treatments or have refused them. They must be in relatively good health (ECOG score of 0 or 1), have adequate organ function, and if they've had cancer immunotherapy, it should include a CPI. Women must test negative for pregnancy and all participants agree to contraception.Check my eligibility
What is being tested?
MT-6402 is being tested in this Phase 1 trial. It's an Engineered Toxin Body (ETB) aimed at treating patients whose solid tumors express the protein PD-L1. The study involves escalating doses to determine safety and effectiveness, followed by expansion to further assess these parameters.See study design
What are the potential side effects?
While specific side effects of MT-6402 aren't listed here, similar drugs often cause immune-related reactions, inflammation in various organs, fatigue, nausea, liver enzyme changes, potential allergic reactions to components like kanamycin or other aminoglycosides.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have taken a pregnancy test within the last 3 days and it was negative.
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My NSCLC has returned or spread and standard treatments aren't suitable for me.
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I have a PD-L1 positive tumor, have tried treatments, and standard options aren't suitable for me.
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I am over 18 with a PD-L1 positive advanced cancer that cannot be treated with standard methods.
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I am over 18, have advanced cancer with PD-L1, and standard treatments aren't suitable for me.
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My cancer in the head or neck area cannot be treated with standard methods, or such treatments are not suitable for me.
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I am eligible for both parts A and B of the study.
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My kidneys work well, with a creatinine clearance rate of 50 mL/min or higher.
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My disease can be measured or seen on tests.
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I have been treated with immune checkpoint inhibitors for my cancer.
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My liver functions are within the required range for the trial.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be measured or seen on tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years (parts 1 and 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years (parts 1 and 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirm the recommended Phase 2 dose (RP2D)
Evaluate efficacy of MT-6402 in subjects with advanced cancer by objective response rate (ORR) with RECIST 1.1
Evaluate the safety of MT-6402 in subjects with advanced cancer (solid tumors) and to estimate the maximum tolerated dose (MTD)
+1 more
Secondary outcome measures
Assess additional efficacy parameters
Characterize the PK profile of MT-6402 in subjects with advanced cancer
Evaluate efficacy of MT-6402 in subjects with advanced cancer by ORR with RECIST 1.1
Other outcome measures
Characterize the PD effect of MT-6402 on CMV antigen presentation
Characterize the PD effect of MT-6402 on CMV antigen presentation pre/post-dose
Characterize the PD profile of MT-6402 in subjects with advanced cancer
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: PD-L1 positive advanced cancerExperimental Treatment1 Intervention
Subjects with PD-L1 positive advanced cancer (solid tumors)
Group II: PD-L1 Positive SCCHNExperimental Treatment1 Intervention
Subjects with PD-L1 Positive Squamous Cell Carcinoma of the head and neck (SCCHN), refractory to or ineligible for platinum-based therapy, who received prior PD-1/PD-L1 treatment
Group III: PD-L1 Positive NSCLCExperimental Treatment1 Intervention
Subjects with PD-L1 Positive Lung Carcinoma (NSCLC) who received prior PD-1/PD-L1 treatment
Group IV: Other relapsed/refractory PD-L1 positive solid tumorsExperimental Treatment1 Intervention
Subjects with any other relapsed or refractory PD-L1 positive solid tumor who received PD-1/PD-L1 treatment.

Find a Location

Who is running the clinical trial?

Molecular Templates, Inc.Lead Sponsor
9 Previous Clinical Trials
319 Total Patients Enrolled

Media Library

MT-6402 (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04795713 — Phase 1
Oral Squamous Cell Carcinoma Research Study Groups: Other relapsed/refractory PD-L1 positive solid tumors, PD-L1 Positive SCCHN, PD-L1 Positive NSCLC, PD-L1 positive advanced cancer
Oral Squamous Cell Carcinoma Clinical Trial 2023: MT-6402 Highlights & Side Effects. Trial Name: NCT04795713 — Phase 1
MT-6402 (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795713 — Phase 1

Frequently Asked Questions

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

Has MT-6402 been sanctioned by the FDA?

"With limited data supporting safety and efficacy, MT-6402 received a score of 1."

Answered by AI

What number of health care centers are running this experiment in the city?

"Currently, this medical trial is recruiting patients from 8 different sites located around the United States. These locations encompass Saint Louis, Chicago, and Los Angeles in addition to other cities that are geographically nearby. If you would like to participate in the study it may be beneficial to select a site closeby so as to reduce any necessary travel requirements."

Answered by AI

How many individuals can take part in this experimental research?

"This clinical trial necessitates 138 participants that meet the inclusion requirements. People can partake in this study at Washington University School of Medicine - St. Louis, Saint Louis and Comprehensive Care and Research Center - Chicago, Illinois."

Answered by AI

Are there any open recruitment opportunities for this investigation?

"Per information on clinicaltrials.gov, this experiment is actively seeking participants as of now - the posting date was May 27th 2021 and it was last updated February 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Mary Crowley Cancer Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~36 spots leftby Apr 2025