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
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.
• Subjects must meet the following criteria to be eligible for enrollment into the study:
• 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:
• 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 therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or ChRCC or ccRCC).
• 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:
∙ Cytotoxic chemotherapy - At least 21 days
‣ Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days
‣ Nitrosoureas - At least 6 weeks
‣ Monoclonal antibody(ies) - At least 28 days
‣ Radiotherapy - At least 14 days from local site radiation therapy
• Negative Serum/urine pregnancy test (for subjects of childbearing potential)
⁃ All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.
⁃ Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.