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AMT-116 for Non-Small Cell Lung Cancer

Not yet recruiting at 6 trial locations
YF
Overseen ByYanhong Fu
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Multitude Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial consists of two parts: phase 2 and phase 3.

The goal of phase 2 of this clinical trial is to compare which dose level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype non-small cell lung cancer (NSCLC) in adults. It will also learn about the safety of AMT-116. The main questions it aims to answer are:

* Which level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC?

* What medical problems do participants have when taking AMT-116? The goal of phase 3 of this clinical trial is to compare AMT-116 to study doctor's choice (a kind of retainable treatment for you in the opinion of the study doctor) to see if AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC.

In both parts of this trial, participants will receive AMT-116 or study doctor's choice every 2 weeks until the study doctor thinks you are benefiting from your participation or until your disease progresses or you are unable to tolerate the study drug

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that does not have EGFR mutations. Participants must have already tried platinum-based chemo and immunotherapy, and their cancer has worsened after these treatments.

Inclusion Criteria

I am willing to join the trial, sign consent, and follow all study requirements.
I have at least one tumor that can be measured on a scan.
I am between 18 and 80 years old.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • AMT-116
  • Docetaxel
  • Ramucirumab

Trial Overview

The study compares a new drug called AMT-116 to standard treatments chosen by the doctor (docetaxel alone or with ramucirumab). Patients are randomly assigned to receive either AMT-116 or one of the standard options every two weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: AMT-116 5 mg/kgExperimental Treatment1 Intervention
Group II: AMT-116 4 mg/kgExperimental Treatment1 Intervention
Group III: Investigator's choice of therapy (docetaxel or docetaxel plus ramucirumab)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Multitude Therapeutics Inc.

Lead Sponsor

Trials
6
Recruited
440+

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