A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
Trial Parameters
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Brief 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.
Eligibility Criteria
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 (ACC, uveal melanoma, NET ChRCC or ccRCC) Part B (Dose Expansion): 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 Extensive stage SCLC or iii. Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard