AMG 199 for Stomach Cancer

No longer recruiting at 33 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Autoimmune disorders, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AMG 199 to determine its safety and tolerability for individuals with certain solid tumors, including those in the stomach, colon, and pancreas. The goal is to identify the optimal dose for future studies. Participants should have specific types of cancer that have not responded to or have returned after other treatments. This study may suit those with gastric, gastroesophageal junction, colorectal, or pancreatic cancer that is positive for MUC17 and have undergone multiple previous treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop any anticancer therapy or immunotherapy at least 4 weeks before starting the study medication. 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 AMG 199 is likely to be safe for humans?

Research has shown that AMG 199 is being tested for safety and tolerability in people with certain cancers, such as stomach and pancreatic cancer. In these studies, AMG 199 has demonstrated a unique ability to target and destroy cancer cells by directing the body's immune cells to attack them.

As the research is still in its early stages, detailed safety information remains limited. However, early studies ensure that the treatment is closely monitored for any side effects. Researchers aim to determine the safest and most effective dose of AMG 199.

For those considering joining the trial, it's important to understand that the primary goal is to assess the safety of AMG 199 and identify potential side effects. This ensures that by the time it becomes widely available, the treatment will be as safe and effective as possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for MUC17-positive solid tumors, which typically involve chemotherapy and targeted therapies, AMG 199 works differently by harnessing the body's immune system. AMG 199 is a bispecific T-cell engager that specifically targets the MUC17 protein, found on the surface of certain cancer cells, guiding the immune system to attack these cells more effectively. Researchers are excited about AMG 199 because it offers a novel mechanism of action, potentially leading to improved outcomes for patients with gastric, gastroesophageal, colorectal, and pancreatic cancers. This innovative approach may provide a more precise and powerful treatment option compared to existing therapies.

What evidence suggests that AMG 199 could be an effective treatment?

Research shows that AMG 199, a bispecific T cell engager, is a new treatment designed to help the body's immune system attack cancer cells with the MUC17 protein. Early results suggest that AMG 199 can guide T cells, a type of immune cell, to locate and destroy these cancer cells. The trial includes a dose-exploration phase to estimate the Maximum Tolerated Dose and a dose-expansion phase to confirm safety and efficacy. While more detailed information is still being gathered, this method could be promising for treating certain solid tumors, including stomach and pancreatic cancers. The treatment aims to boost the body's natural defenses against cancer, potentially improving outcomes for patients with these hard-to-treat cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Inclusion Criteria

Key Inclusion Criteria: Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma positive for MUC17. Subjects should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, nivolumab (in combination with a platinum and a fluoropyrimidine), either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI).

OR Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable colorectal cancer positive for MUC17. Subjects should have been refractory to or have relapsed after at least two and up to five prior lines of standard systemic therapy. Therapy should have included an approved vascular endothelial growth factor (VEGF) antibody (if clinically appropriate) and epidermal growth factor receptor (EGFR) antibody (if kirsten rat sarcoma [KRAS]/ neuroblastoma RAS viral oncogene homolog [NRAS]/ v-Raf murine sarcoma viral oncogene homolog B1 [BRAF] wild type tumor).

OR Subjects with histologically or cytologically confirmed unresectable or metastatic pancreatic ductal adenocarcinoma positive for MUC17. Subjects should have been refractory to or have relapsed after at least one and up to three prior lines of standard systemic therapy. Gastric adenocarcinoma and GEJ adenocarcinoma: Subjects eligible for human epidermal growth factor receptor 2 (HER2) directed therapy, prior systemic therapy should have an approved HER2 targeting antibody approved for treatment of gastric cancer. For subjects with microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) tumors a prior line of treatment should have included an approved programmed cell death protein-1 (PD-1) blocking antibody.

Exclusion Criteria

You have received any cancer treatment or immunotherapy within 4 weeks before starting the study. You have cancer that has spread to your brain or spinal cord, or you have an autoimmune disorder and are taking medication to suppress your immune system. However, you may be eligible if you stopped taking the medication over 3 months ago and your doctor agrees that it is unlikely to cause a relapse of your autoimmune disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-exploration

The dose-exploration phase of the study will estimate the MTD of AMG 199 using a Bayesian logistic regression model. A RP2D may be identified based on emerging safety, efficacy, and PD data.

Variable

Dose-expansion

The dose-expansion phase will confirm safety, PK, and PD at the MTD or RP2D and obtain further safety and efficacy data.

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• AMG 199

How Is the Trial Designed?

Group I: Dose-exploration phase Experimental Treatment 1 Intervention

The dose-exploration phase of the study will estimate the MTD (Maximum Tolerated Dose) of AMG 199 using a Bayesian logistic regression model (BLRM). A RP2D (Recommended Phase 2 Dose) may be identified based on emerging safety, efficacy, and PD (Pharmacodynamics) data prior to reaching an MTD. Alternative dosing schedule(s) may be explored based on emerging PK (Pharmacokinetics) and safety data.

Group II: Dose-expansion phase Experimental Treatment 1 Intervention

The dose-expansion phase will be conducted to confirm safety, PK, and PD at the MTD or RP2D and to obtain further safety and efficacy data and enable correlative biomarker analysis.

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/NCT04117958

Study of AMG 199 in Subjects With MUC17-Positive Solid ...

AMG 199 is a novel half-life extended (HLE) bispecific T cell engager (BiTE®) molecule designed to direct T cells towards MUC17-expressing cells.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.TPS4649

Trial in progress: A phase I study of AMG 199, a half-life ...

AMG 199 is an HLE BiTE immune therapy designed to engage CD3-positive T cells to MUC17-positive G/GEJ cancer cells, mediate redirected tumor cell lysis, and ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/f7b95dc49516aeda/nct04117958-global-phase-1-study-amg-199-solid-tumors

Study of AMG 199 in Subjects With MUC17-Positive Solid ...

AMG 199 is a novel half-life extended (HLE) bispecific T cell engager (BiTE®) molecule designed to direct T cells towards MUC17-expressing cells.

4.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/amgen-zai-lab-gastric-cancer/

Amgen and Zai Lab's trial of gastric cancer therapy meets ...

Key secondary outcome measures are overall response rate (ORR) and progression-free survival (PFS). Notably, the trial incorporated more ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9146966/

Bispecific Antibody-Based Immune-Cell Engagers and ...

AMG 199 is an HLE-BiTE molecule against CD3 and MUC17. It induces the activation and proliferation of CD3+ T-cells and activates T-cell-mediated tumor-cell ...

6.

onderzoekmetmensen.nl

onderzoekmetmensen.nl/en/node/56431/pdf

A Global Phase 1 Study Evaluating the Safety, Tolerability, ...

AMG 199 is an HLE BiTE * antibody construct designed to direct T cells towards MUC17-expressing cells. In AMG 199 the binding arms for MUC17 and ...

7.

medchemexpress.com

medchemexpress.com/vepsitamab.html?srsltid=AfmBOoq1eXB1PEY9ESF_HwZ5_FedafJpKLN3niroc4uC_ncs65-yVn-p

Vepsitamab (AMG 199) | Anti-MUC17/CD3 Antibody

Vepsitamab (AMG 199) is an anti-MUC17/CD3 BiTE antibody that binds to CD3 on T cells and MUC17 expressed on tumor cells, mediates redirected tumor cell lysis, ...

8.

mycancergenome.org

mycancergenome.org/content/clinical_trials/NCT04117958/

Clinical Trial: NCT04117958

To evaluate the safety and tolerability of AMG 199 in adult subjects with MUC17-positive gastric and gastroesophageal junction cancer and to ...

9.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT04117958/

Trial | NCT04117958

The primary end point is to evaluate the safety and tolerability of AMG 199 in adult subjects, and determine the MTD and RP2D. The secondary end point is ...