Trials / Completed
CompletedNCT03406949
MGD009/MGA012 Combination in Relapsed/Refractory Cancer
A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (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 obrindatamab administered in combination with retifanlimab in patients with B7-H3- expressing tumors.
Detailed description
This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of obrindatamab and retifanlimab, each of which is administered by IV infusion. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | obrindatamab | B7-H3 x CD3 DART protein |
| BIOLOGICAL | retifanlimab | anti-PD-1 antibody |
Timeline
- Start date
- 2018-02-27
- Primary completion
- 2022-04-27
- Completion
- 2022-04-27
- First posted
- 2018-01-23
- Last updated
- 2022-05-19
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03406949. Inclusion in this directory is not an endorsement.