512 Participants NeededMy employer runs this trial

AMT-116 for Non-Small Cell Lung Cancer

Recruiting at 6 trial locations
YF
Overseen ByYanhong Fu
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 trial aims to determine if a new drug, AMT-116, can more effectively treat advanced non-squamous EGFR-Wildtype non-small cell lung cancer (NSCLC). It will compare different dose levels of AMT-116 and evaluate its performance against existing treatments like docetaxel, a common chemotherapy drug. The study focuses on the drug's effectiveness and safety, including any side effects. Individuals with this specific type of lung cancer, whose disease has progressed despite prior treatments, might be suitable candidates for the trial. Participants will receive treatments every two weeks as long as they benefit or until their condition worsens. As a Phase 2, Phase 3 trial, this study assesses the efficacy of AMT-116 and represents the final step before FDA approval, offering hope for improved treatment options.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AMT-116, a treatment for non-small cell lung cancer, has been studied for safety and patient tolerance. In earlier studies, AMT-116 was mostly safe, though some patients experienced side effects like nausea or fatigue. Researchers are testing different doses to determine the safest and most effective amount.

AMT-116 is an antibody-drug conjugate (ADC), combining an antibody, which fights germs, with a drug that kills cancer cells. This combination aims to target cancer cells more precisely, potentially reducing side effects compared to traditional chemotherapy. Although AMT-116 is still under study, early results suggest it is generally well-tolerated by patients.

Prospective trial participants should discuss potential risks and benefits with the study team and their doctor, based on the latest research findings.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for non-small cell lung cancer, which typically include chemotherapy agents like docetaxel and targeted therapies, AMT-116 offers a novel approach. AMT-116 is unique because it involves a new mechanism of action that targets specific cancer pathways more precisely. Researchers are particularly excited about AMT-116 due to its potential to enhance effectiveness and reduce side effects compared to existing options. Additionally, the different dosage levels being tested, 4 mg/kg and 5 mg/kg, provide opportunities to optimize treatment effectiveness and potentially personalize therapy for patients.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that AMT-116 is part of a new treatment class called antibody-drug conjugates (ADCs), which hold promise for lung cancer. ADCs function by attaching a drug to an antibody that targets cancer cells, delivering the drug directly to the tumor. Early signs suggest that ADCs like AMT-116 can improve survival and outcomes for people with certain types of lung cancer. In this trial, participants may receive AMT-116 at varying dosages or the investigator's choice of therapy, which includes docetaxel or a combination of docetaxel and ramucirumab. Studies have demonstrated that these treatments can remain effective over time. Confidence in ADCs for non-small cell lung cancer is growing, offering new hope for patients.678910

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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 2

Participants receive AMT-116 to determine the optimal dose and assess safety

Until disease progression or intolerance
Every 2 weeks

Treatment Phase 3

Participants receive AMT-116 or investigator's choice to compare effectiveness

Until disease progression or intolerance
Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+

Citations

Real-world survival outcomes in non–small cell lung cancer

This study used a novel dataset derived from the electronic health records of over 2,600 UK patients diagnosed with NSCLC between 2016 and 2024.

Unleashing the Power of ADCs in Lung Cancer Treatment

ADCs are likely to continue to be successful in clinical use and may represent a new paradigm in lung cancer treatment in the future.

'Targeting' Improved Outcomes with Antibody-Drug ...

In this comprehensive review, we will be discussing the recent evidence including targets, efficacy and the safety of newer ADC candidates in NSCLC.

Advances in Non-small Cell Lung Cancer Treatment

Nivolumab (anti-PD-1 antibody) and atezolizumab (anti-PD-L1 antibody) have shown superior survival outcomes and improved adverse effects compared to standard ...

Novel Antibody-Drug Conjugates in Advanced NSCLC

We've seen some updated data for datopotamab deruxtecan or Dato-DXd showing benefit in non-squamous non-small cell lung cancer in the second-line population and ...

AMT-116 in Patients With Advanced Solid Tumors

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, ...

Clinical Trial Evaluating the Safety, Tolerability and ...

Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone. With Advanced Non-small Cell Lung Cancer

Unleashing the Power of ADCs in Lung Cancer Treatment

ADCs are likely to continue to be successful in clinical use and may represent a new paradigm in lung cancer treatment in the future.

Antibody-Drug Conjugate Safety Profiles in NSCLC

Garon, MD, MS, reviews the safety profiles of sacituzumab govitecan and datopotamab deruxtecan in patients with non–small cell lung cancer.