AMG 410 for Cancer

Recruiting at 5 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Chemotherapy, Antibody therapy

Disqualifiers: CNS metastases, Infection, Thrombosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

434 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AMG 410 for individuals with advanced or metastatic solid tumors that have changes in the KRAS gene. The main goal is to determine the safety of AMG 410 and identify the appropriate dose, either alone or with other treatments. Researchers administer different doses to participants to observe their body's reactions, and the trial also examines the effect of food on the treatment. It suits those with KRAS-altered cancers, such as certain lung or colorectal cancers, who have no other treatment options. As a Phase 1 trial, this research aims to understand how AMG 410 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any anti-tumor therapy at least 28 days before the first dose of the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

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

Earlier research showed that AMG 410 has strong potential in fighting tumors, particularly in cancers with KRAS mutations. While this is encouraging, the current study remains in its early stages, so complete safety information is not yet available.

Researchers are testing AMG 410 in combination with pembrolizumab and panitumumab to determine safe and tolerable doses. Previous studies on similar drug combinations mostly reported mild side effects, but specific information for AMG 410 is still being collected.

As a Phase 1 trial, the main goal is to find the best dose with manageable side effects. While the treatment is being tested for safety, some unknowns remain. Participants should consider that this research is in its early stages when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AMG 410 because it targets KRAS mutations, which are found in several tough-to-treat cancers like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Unlike the standard treatments that might include chemotherapy or targeted therapies like pembrolizumab and panitumumab, AMG 410 is designed to directly tackle these mutations, potentially offering a more precise attack on cancer cells. Additionally, the treatment explores various combinations with other drugs, such as pembrolizumab and panitumumab, which could enhance its effectiveness and broaden its use against advanced or metastatic cancers. This innovative approach could lead to more personalized and effective cancer treatment options.

What evidence suggests that AMG 410 could be an effective treatment for KRAS-altered tumors?

Research has shown that AMG 410 yields promising results in treating cancers with KRAS mutations. Early studies demonstrated its effectiveness against tumors, particularly solid ones with these mutations, such as non-small cell lung cancer and pancreatic cancer. In this trial, participants will receive AMG 410 in various treatment arms. Some will receive AMG 410 alone, while others will receive it combined with treatments like pembrolizumab and panitumumab to assess its potential to enhance cancer-fighting effects. Initial signs are positive, but further research is necessary for confirmation. Overall, AMG 410 is under careful study for its potential to target and treat challenging KRAS-altered tumors. ^{1 2 3 4 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that have a KRAS alteration. Participants should be able to receive AMG 410, either alone or with Panitumumab/Pembrolizumab. Specific eligibility criteria are not provided, but typically include factors like health status and prior treatments.

Inclusion Criteria

I am at least 18 years old or the legal age in my country.

Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator

My cancer has a KRAS gene mutation or KRAS amplification.

Exclusion Criteria

I don't have any health conditions that would make it unsafe for me to join.

I have not had any other cancer in the last 5 years.

I have not received any live vaccines in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of AMG 410 to determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)

Variable duration until MTD or RP2D is determined

Dose Expansion

Additional expansion cohorts are enrolled at selected dose levels to further characterize safety, PK/PD relationships, and preliminary efficacy

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMG 410

Trial Overview The study tests the safety and effects of AMG 410 on its own or combined with Panitumumab/Pembrolizumab in treating certain cancers. It's a dose-escalation study aiming to find the highest safe dose (MTD) or the recommended dose for future Phase 2 trials (RP2D).

How Is the Trial Designed?

Group I: Part 3b: Combination Therapy Dose Exploration and Dose Expansion Experimental Treatment 2 Interventions

Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC.

Group II: Part 3a: Combination Therapy Dose Exploration and Dose Expansion Experimental Treatment 2 Interventions

Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors.

Group III: Part 2: Monotherapy Dose Expansion Experimental Treatment 1 Intervention

Monotherapy dose expansion of AMG 410 may proceed in KRAS altered tumors in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and other KRAS altered tumor types.

Group IV: Part 1: Monotherapy Dose Exploration Experimental Treatment 1 Intervention

Participants will receive escalating doses of AMG 410.

Group V: Part 1: Food Effect Substudy Cohort Experimental Treatment 1 Intervention

A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions.

Group VI: Part 1: China-specific Cohort Experimental Treatment 1 Intervention

Participants identified through regionally approved molecular KRAS testing will receive AMG 410.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07094113

Study Details | NCT07094113 | AMG 410 Alone and in ... The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ...

2. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-6-2025-2bfe8

AMG 410 for Cancer · Recruiting Participants for Phase ... This Phase 1 medical study run by Amgen is evaluating whether AMG 410 will have tolerable side effects & efficacy for patients with Lung Cancer, Colorectal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11097198/

KRAS G12C inhibitor combination therapies In each cohort, TRAEs leading to discontinuing the regimen were observed in 3.8% and 1.9%. As for the efficacy, ORR was 26.4% and 5.7%, and mPFR ...

4. hematologyandoncology.net hematologyandoncology.net/archives/march-2025-and-april-2025/targeting-ras-in-gastrointestinal-malignancies/

Targeting RAS in Gastrointestinal Malignancies This review explores the molecular biology of KRAS mutations, their prevalence in GI malignancies, the current therapeutic approaches targeting KRAS, ongoing ...

5. synapse.patsnap.com synapse.patsnap.com/article/fda-approves-amgens-colorectal-cancer-combo-therapy

FDA Approves Amgen's Colorectal Cancer Combo Therapy The trial successfully met its primary goal by showing a substantial increase in progression-free survival. The median PFS for patients ...

6. vectibixhcp.com vectibixhcp.com/efficacy/paradigm-clinical-data

PARADIGM Study Design & Clinical Data Assess design, outcome and safety information from the PARADIGM phase 3 study of newly diagnosed patients with WT RAS mCRC. See Prescribing and Safety Info ...