Trials / Completed
CompletedNCT05293496
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor in Participants With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .
Conditions
- Advanced Solid Tumor
- Castration-Resistant Prostatic Cancer
- Malignant Melanoma
- Pancreatic Ductal Carcinoma
- Hepatocellular Cancer
- Epithelial Ovarian Cancer
- Renal Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | vobramitamab duocarmazine | Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3. |
| BIOLOGICAL | lorigerlimab | Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4. |
Timeline
- Start date
- 2022-04-19
- Primary completion
- 2025-06-24
- Completion
- 2025-08-26
- First posted
- 2022-03-24
- Last updated
- 2025-10-14
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05293496. Inclusion in this directory is not an endorsement.