Trials / Recruiting
RecruitingNCT06242470
A Study of MGC026 in Participants With Advanced Solid Tumors
A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
Conditions
- Advanced Solid Tumor
- Advanced Cancer
- Metastatic Cancer
- Squamous Cell Carcinoma of Head and Neck
- Non Small Cell Lung Cancer
- Small-cell Lung Cancer
- Bladder Cancer
- Sarcoma
- Endometrial Cancer
- Melanoma
- Castration Resistant Prostatic Cancer
- Cervical Cancer
- Colorectal Cancer
- Gastric Cancer
- Gastro-esophageal Cancer
- Pancreas Cancer
- Clear Cell Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Platinum-resistant Ovarian Cancer
- Breast Cancer
- Ovarian Cancer
- Esophageal Squamous Cell Cancer (SCC)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MGC026 Dose Escalation | Escalating doses of MGC026 |
| BIOLOGICAL | MGC026 Dose for Expansion | MGC026 recommended dose for expansion |
Timeline
- Start date
- 2024-03-06
- Primary completion
- 2028-05-01
- Completion
- 2028-10-01
- First posted
- 2024-02-05
- Last updated
- 2026-02-05
Locations
12 sites across 3 countries: United States, Australia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06242470. Inclusion in this directory is not an endorsement.