A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid… (NCT06805825) | Clinical Trial Compass
RecruitingPhase 1
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
United States67 participantsStarted 2025-02-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.
✓. Subjects must have received the following treatment:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.
✓. Age ≥ 18 years.
✓. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).
✓. Adequate heart function as measured by ECHO/MUGA scan.
✓. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:
Exclusion criteria
✕. Has received prior therapy with a c-Kit agent (except GIST subjects).
✕. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
✕. A condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs (inhaled corticosteroids are allowed).
✕. Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at Study Entry, Day -2 to Cycle 1 Day 1.
✕. Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).