Conditions: Advanced Gastrointestinal Malignancies
Keywords: Phase 1, Advanced gastrointestinal malignancies, MLN0264, Guanylyl Cyclase C(GCC), Antibody Drug Conjugate(ADC)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.

Detailed description:

Arms:
arm 1: MLN0264 starting dose 0.3 mg/kg escalated until Maximum Tolerated Dose (MTD) was determined, 30-minute infusion, on Day 1 of each 21-Day treatment cycle.

Interventions: intervention 1: MLN0264
Intervention descriptions: intervention 1: MLN0264 30-minute infusion on Day 1 of each treatment cycle

Protocol document: