A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
Novelty Nobility, Inc.
Summary
This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and/or metastatic solid tumors known to express c-Kit.
Description
The drug being tested in this study is called NN3201, a c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE, administered by IV. The study will be conducted in two parts, a dose escalation phase (Part A) followed by an expansion phase (Part B). The patient population for the dose escalation phase (Part A) of the study will include patients with advanced and/or metastatic c-Kit-associated solid tumors including gastrointestinal stromal tumor (GIST), adenoid cystic carcinoma (ACC), uveal melanoma, neuroendocrine tumors (NET), and chromophobe and clear cell renal cell carcin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: Subjects must meet the following criteria to be eligible for enrollment into the study: 1. Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC. 2. Subjects must have received the following treatment: Part A (Dose Escalation): i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or ii. Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors…
Interventions
- DrugNN3201
A c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously.
Locations (5)
- University of Michigan HospitalsAnn Arbor, Michigan
- Case Comprehensive Cancer CenterCleveland, Ohio
- Oregon Health & Science UniversityPortland, Oregon
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- NEXT VirginiaFairfax, Virginia