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MT-8421 + Nivolumab for Advanced 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

Part A only: Evaluable only or measurable disease according to RECIST v1.1 Part B only: At least 1 measurable tumor lesion according to RECIST v1.1

Eastern Cooperate Oncology Group (ECOG) performance score of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years (parts a and b)

Awards & highlights

Study Summary

This trial studies a new drug to treat advanced solid cancers by targeting and depleting cells associated with the tumor microenvironment.

Who is the study for?

This trial is for adults with certain advanced solid cancers, including melanoma and lung cancer, who have already tried a PD-1 or PD-L1 inhibitor. They must be able to undergo biopsies, not be on other cancer treatments, and women of childbearing potential need a negative pregnancy test. Good organ function and performance status are required.Check my eligibility

What is being tested?

The study tests MT-8421 alone and combined with Nivolumab in patients with specific advanced cancers. It's an early-phase trial to find the right dose and see how well these drugs work together against tumors by targeting CTLA-4 expressing cells.See study design

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in organs (pneumonitis), infusion reactions from the drug entering the body, fatigue, blood disorders that affect cell counts, liver enzyme changes indicating liver stress, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Part A: Your disease can be evaluated. Part B: You have at least one tumor that can be measured.

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I am fully active or have some restrictions but can still care for myself.

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My blood tests show enough white blood cells, platelets, and hemoglobin.

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My kidneys work well, with a creatinine clearance rate of 50 mL/min or higher.

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I have a tumor that can be safely biopsied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years (parts a)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years (parts a)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years (parts a) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with Adverse Events

Proportion of participants with objective response

To confirm the recommended Phase 2 dose (RP2D) of MT-8421 as monotherapy and in combination with nivolumab in patients with selected advanced solid tumor types.

Secondary outcome measures

Characterize the pharmacokinetic (PK) profile of MT-8421 given as monotherapy and in combination with nivolumab in patients with selected advanced solid tumor types

Disease control rate to assess preliminary efficacy

Duration of response to assess preliminary efficacy

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part B Dose Expansion MonotherapyExperimental Treatment1 Intervention

Part B- Dose expansion of MT-8421 monotherapy in patients with selected advanced solid tumors. Part B monotherapy will include two expansion groups: Group B1 (NSCLC) and group B2 (HCC). The assigned dose level of MT-8421 determined in Part A 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, day 15, and day 22 of each 28-day cycle).

Group II: Part B Dose Expansion CombinationExperimental Treatment2 Interventions

Part B- Dose escalation of MT-8421 in combination with nivolumab in patients with selected advanced solid tumors. Part B combination therapy will include two expansion groups: Group B3 (Melanoma) and Group B4 (RCC). The assigned dose level of MT-8421 determined in Part A will be given as an intravenous (IV) infusion over about 30 minutes prior to the infusion of 480 mg nivolumab. MT-8421 will be given on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle). Nivolumab will be given on the first day of each cycle beginning at cycle 2.

Group III: Part A- Dose Escalation MonotherapyExperimental Treatment1 Intervention

Part A- Dose escalation of MT-8421 monotherapy in patients with selected advanced solid tumors. The assigned dose level of MT-8421 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, day 15, and day 22 of each 28-day cycle).

Group IV: Part A- Dose Escalation Combination TherapyExperimental Treatment2 Interventions

Part A- Dose escalation of MT-8421 in combination with nivolumab in patients with selected advanced solid tumors. The assigned dose level of MT-8421 will be given as an intravenous (IV) infusion over about 30 minutes prior to the infusion of 480 mg nivolumab. MT-8421 will be given on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle). Nivolumab will be given on the first day of each cycle beginning at cycle 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Molecular Templates, Inc.Lead Sponsor

9 Previous Clinical Trials

257 Total Patients Enrolled

Admasu Mamuye, MDStudy DirectorMolecular Templates

Frequently Asked Questions

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

Could you please elucidate the hazard of Part A- Dose Escalation Monotherapy for patients?

"The safety of Part A- Dose Escalation Monotherapy is initially estimated to be a 1 due to this being an early Phase 1 trial, meaning that available data supporting its efficacy and safety is limited."

Answered by AI

Are individuals being asked to join this research endeavor at the present time?

"According to clinicaltrials.gov, this research exploration is currently recruiting participants - the trial was initially published on September 1st 2023 and had its most recent update released five days later."

Answered by AI

How many individuals are being monitored for this clinical experiment?

"This trial needs 200 eligible candidates from two distinct locations, Horizon Oncology Research in Lafayette and Washington University in St. Louis, to participate."

Answered by AI

How widespread is the implementation of this experiment?

"This medical research is currently taking place at Horizon Oncology Research in Lafayette, Indiana, Washington University in St. Louis and Weill Cornell Medicine in New york City. Additionally, 5 other sites are participating this trial as well."

Answered by AI

What are the major goals of this experimental endeavor?

"According to the trial's sponsor Molecular Templates, Inc., this medical study will be measuring its primary outcome over a 28 day cycle interval; that is to confirm the recommended Phase 2 dose (RP2D) of MT-8421 both as monotherapy and in conjunction with nivolumab. Furthermore, secondary objectives such as duration of response, time to response, and progression-free survival are being used to assess preliminary efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types

2023. "Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034860.

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