Trials / Terminated
TerminatedNCT03729596
MGC018 With or Without MGA012 in Advanced Solid Tumors
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Cancer
- Melanoma
- Advanced Solid Tumor, Adult
- Metastatic Castrate Resistant Prostate Cancer
- Non Small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | vobramitamab duocarmazine | Anti-B7H3 antibody drug conjugate |
Timeline
- Start date
- 2018-11-21
- Primary completion
- 2023-03-18
- Completion
- 2023-03-18
- First posted
- 2018-11-02
- Last updated
- 2025-07-31
- Results posted
- 2025-07-31
Locations
21 sites across 4 countries: United States, Australia, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03729596. Inclusion in this directory is not an endorsement.