Trials / Completed
CompletedNCT02982941
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients With B7-H3-Expressing Relapsed or Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 1 Year – 35 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
Detailed description
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors. The study consists of a Dose Escalation Phase to determine the MTD (or MAD) of enoblituzumab followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of enoblituzumab. In the cohort expansion phase, 5 cohorts of 10 patients each will be enrolled to further evaluate the safety and potential efficacy of enoblituzumab administered at the MTD/MAD in patients with:1) neuroblastoma - measurable disease, 2) neuroblastoma - non-measurable disease, 3) rhabdomyosarcoma, 4) osteosarcoma, and 5) Ewing's sarcoma, Wilms' tumor, desmoplastic small round cell tumors, or malignant solid tumors of any other histology that test positive for B7-H3. All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC). Disease assessment in patients with neuroblastoma will use neuroblastoma overall response criteria.
Conditions
- Neuroblastoma
- Rhabdomyosarcoma
- Osteosarcoma
- Ewing Sarcoma
- Wilms Tumor
- Desmoplastic Small Round Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enoblituzumab | enoblituzumab administered IV weekly for up to 96 weeks |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2019-05-22
- Completion
- 2019-05-22
- First posted
- 2016-12-06
- Last updated
- 2022-02-08
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02982941. Inclusion in this directory is not an endorsement.