Study of NN3201 for Advanced c-Kit Expressing Solid Tumors

This study is testing a new treatment called NN3201 for people with advanced or metastatic (spread to other parts of the body) solid tumors that express c-Kit. NN3201 is an antibody-drug conjugate, which means it's designed to deliver a powerful drug directly to cancer cells that have a specific marker called c-Kit. The main goal of this study is to find out how safe NN3201 is and what side effects it might cause. You could be eligible if you have certain types of cancer like gastrointestinal stromal tumors (GIST), small-cell lung cancer (SCLC), adenoid cystic carcinoma (ACC), uveal melanoma, or neuroendocrine tumors (NET), and have already received some treatments. The study plans to enroll 67 participants.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 67 participants and has two parts: a dose escalation phase and an expansion phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06805825

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novelty Nobility, Inc.
~67 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:NN3201

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with Dose-limiting Toxicities:
Measured over 3 weeks
+1 more outcome measured
Gastrointestinal Stromal Tumors
Small-cell Lung Cancer
Adenoid Cystic Carcinoma
Uveal Melanoma
Neuroendocrine Tumors
Chromophobe Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
5 sites across 5 states
Michigan1
Ohio1
Oregon1
Texas1
Virginia1
  • Sunil Sharma, MD · PRINCIPAL_INVESTIGATOR · Novelty Nobility

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  • Number of subjects with Dose-limiting Toxicities:3 weeks

    A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.

  • Incidence of Adverse Events:1 year

    Number of subjects with adverse events (AEs) according to severity, seriousness, and relationship to study drug