A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovelty Nobility, Inc.

About this trial

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

Qualifiers

Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET 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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NN3201

Treatment groups

67 Participants
are divided into 4 treatment groups

Sponsors and collaborators