MGC018 With or Without MGA012 in Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 193
Summary
- Conditions
- Advanced Solid Tumor, Adult
- Melanoma
- Metastatic Castrate Resistant Prostate Cancer
- Non -Small Cell Lung Cancer
- Prostate Cancer
- Squamous Cell Carcinoma of Head and Neck
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Dose escalation will use a 3+3+3 design to identify an MAD or MTD, followed by a Cohort Expansion.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This Phase 1/2 study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) and anti-tumor activity for MGC018 as monotherapy (Module A) in patients with advanced solid tumors. Each module consists of a Dose Escalation (3+3+3 design) followed by ...
This Phase 1/2 study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) and anti-tumor activity for MGC018 as monotherapy (Module A) in patients with advanced solid tumors. Each module consists of a Dose Escalation (3+3+3 design) followed by a Cohort Expansion Phase. Patients with solid tumors will be enrolled in the Dose Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose. Module B, MGC018 in combination with MGA012, Dose Escalation and Cohort Expansion will commence only upon sponsor notification to all study investigators.
Tracking Information
- NCT #
- NCT03729596
- Collaborators
- Not Provided
- Investigators
- Study Director: Chet Bohac, PharmD MD MSc MacroGenics