Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal… (NCT04117958) | Clinical Trial Compass
TerminatedPhase 1
Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers
Stopped: Business decision
United States, Austria, France58 participantsStarted 2020-01-20
Plain-language summary
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* …
What they're measuring
1
Incidence of Dose-limiting toxicities (DLT)
Timeframe: 3 years
2
Incidence of Treatment-emergent adverse events (TEAEs)
Timeframe: 3 years
3
Incidence of Treatment-related adverse events (TRAEs)
Timeframe: 3 years
4
Number of subjects with changes in vital signs
Timeframe: 3 years
5
Number of subjects with changes in clinical laboratory tests
Timeframe: 3 years
6
Number of subjects with changes in electrocardiogram (ECG)