Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

Recruiting at 28 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

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

Compensation: Varies

Number of Visits: Unknown

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing AMG 199, a new medicine that helps the immune system fight certain cancers. It targets adults with cancers that have a specific marker (MUC17). The medicine guides immune cells to attack these cancer cells.

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.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

Interventions

• AMG 199

Participant Groups

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