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MT-8421 + Nivolumab for Advanced Solid Cancer Types

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

Adequate renal function, based on estimated creatinine clearance (eCrCl) ≥ 50 mL/min, calculated by the Cockcroft-Gault equation.

Availability of a lesion that can be biopsied with acceptable risk.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to two years (parts a and b)

Awards & highlights

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Oral Squamous Cell Carcinoma
Non-Small Cell Lung Cancer
Melanoma
Cervical Cancer
Liver Cancer
Microsatellite Instability
Lynch Syndrome
Esophageal Cancer
Kidney Cancer
Bladder Cancer
Mesothelioma
Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

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

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Your kidneys work well enough, with a certain level of creatinine clearance.

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There is a place on your body where a small piece of tissue can be safely removed for testing.

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You have been diagnosed with advanced or metastatic melanoma, HCC, NSCLC, RCC, MSI-H/dMMR malignancies, urothelial carcinoma, esophageal squamous cell carcinoma, mesothelioma, SCCHN, or cervical carcinoma, and standard treatment options are not suitable for you.

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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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You have been treated with a specific type of medication that helps the immune system fight cancer.

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You are in good enough physical condition to perform everyday activities or can do some physical activities.

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You need to have enough healthy blood cells, as measured by specific counts of white blood cells, platelets, and hemoglobin.

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Your liver function is normal, as shown by specific blood tests for bilirubin, AST, ALT, and albumin levels.

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If you can have children, you need to have a negative pregnancy test before starting treatment. If you are past menopause or cannot have children, this rule may not apply to you.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4120

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Molecular Templates, Inc.Lead Sponsor

9 Previous Clinical Trials

297 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 n 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 n 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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