MGC018 With or Without MGA012 in Advanced Solid Tumors
Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of vobramitamab duocarmazine (MGC018) in patients with advanced solid tumors. 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.
Timeline
- Start
- 2018-11-21
- Primary completion
- 2023-03-18
- Completion
- 2023-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vobramitamab duocarmazine | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | vobramitamab duocarmazine | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | vobramitamab duocarmazine | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | vobramitamab duocarmazine | Other / unclassified | 3 mg/kg | Intravenous |
| Subject | vobramitamab duocarmazine | Other / unclassified | 4 mg/kg | Intravenous |