AMG 436 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, AMG 436, for individuals with advanced solid tumors that have specific genetic markers known as MSI-H or dMMR. The primary goal is to assess the safety of AMG 436 and determine the optimal dose, whether used alone or with other cancer treatments. Participants will be divided into groups to test AMG 436 alone, with food, or in combination with other therapies. Ideal candidates are those with an MSI-H or dMMR tumor in an advanced or metastatic state. As a Phase 1 trial, this research aims to understand how AMG 436 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that AMG 436 is likely to be safe for humans?
Research has shown that AMG 436 is a new treatment currently undergoing testing to ensure its safety. The main goal is to assess tolerability and determine the optimal dose. As this study is in its early stages, limited information is available about its safety. These initial studies typically focus on identifying side effects and establishing a safe dose for patients.
If AMG 436 had already received approval for another use, it might increase confidence in its safety. However, participants should be aware that the treatment is still under evaluation to confirm its safety and establish the correct dosage.12345Why do researchers think this study treatment might be promising for cancer?
Researchers are excited about AMG 436 because it offers a novel approach to cancer treatment. Unlike traditional therapies that may target cell growth broadly, AMG 436 is designed to act more precisely on cancer cells, potentially reducing harm to healthy cells. This targeted action could lead to fewer side effects and improved outcomes for patients. Additionally, the trial explores various combinations, including using AMG 436 with chemotherapy, which might enhance its effectiveness and offer more personalized treatment options.
What evidence suggests that AMG 436 might be an effective treatment for cancer?
Research has shown that AMG 436 is a new treatment under investigation for its potential to treat certain cancers with specific genetic features, known as MSI-H/dMMR solid tumors. The trial consists of several parts to evaluate AMG 436: Part 1A involves monotherapy dose escalation, Part 1B examines the food effect under fasted and fed conditions, Part 2 explores AMG 436 in combination dose escalation, Part 3 focuses on monotherapy dose expansion and optimization, and Part 4 investigates AMG 436 in combination with chemotherapy. Early results suggest that AMG 436 might be effective, particularly when combined with other cancer treatments, but detailed information on its effectiveness in humans remains limited. The main goal of ongoing studies is to determine the safest and most effective dose. These early studies are crucial steps before larger trials can confirm its efficacy against these cancer types.12356
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Part 1A
AMG 436 monotherapy dose escalation
Treatment - Part 1B
Food Effect Substudy: Participants receive AMG 436 under fasted and fed conditions
Treatment - Part 2
AMG 436 + combination dose escalation
Treatment - Part 3
AMG 436 monotherapy dose expansion and optimization
Treatment - Part 4
AMG 436 + chemotherapy combination dose expansions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AMG 436
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
AMG 436 + chemotherapy combination dose expansions.
AMG 436 monotherapy Dose expansion and optimization.
AMG 436 + combination dose escalation.
Participants will receive AMG 436 under fasted and fed conditions (United States only).
AMG 436 monotherapy dose escalation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Study Details | NCT07403721 | AMG 436 as Monotherapy ...
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/867575/amgen-expands-oncology-pipeline-with-new-phase-1-amg-436-study-in-msi-hdmmr-tumors/Amgen Expands Oncology Pipeline With New Phase 1 ...
The main treatment is AMG 436, an experimental cancer ... 436 will likely need either better tolerability or strong combo data to stand out.
3.
ctv.veeva.com
ctv.veeva.com/study/amg-436-as-monotherapy-and-combination-therapy-in-participants-with-msi-h-dmmr-solid-tumorsAMG 436 as Monotherapy and Combination Therapy in ...
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or ...
Antibody-drug conjugates combinations in cancer treatment
Here we will review combinations of ADCs with other antitumor agents aiming at describing the current state of the art and future directions.
AMG 436 Safety and Dose Evaluation in MSI-H/dMMR ...
This phase 1 study aims to evaluate the safety and find the appropriate dose of AMG 436 in individuals with MSI-H/dMMR solid tumors, by observing the number of ...
AMG 436 as Monotherapy and Combination Therapy in ...
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose ...
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