OncoMatch/Clinical Trials/NCT06805825
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
Is NCT06805825 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NN3201 for gastrointestinal stromal tumors.
Treatment: NN3201 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Melanoma
Neuroendocrine Tumor
Renal Cell Carcinoma
Biomarker criteria
Required: KIT overexpression
Advanced and/or metastatic solid tumors known to express c-Kit
Disease stage
Metastatic disease required
Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: tyrosine kinase inhibitor (imatinib) — GIST
Treatment with imatinib for GIST (at least one line of therapy with imatinib)
Must have received: standard therapy — c-Kit-associated solid tumors (ACC, uveal melanoma, NET, ChRCC or ccRCC)
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)
Must have received: standard therapy — Extensive stage SCLC
Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC
Cannot have received: c-Kit agent
Exception: except GIST subjects
Has received prior therapy with a c-Kit agent (except GIST subjects)
Lab requirements
Blood counts
Laboratory values demonstrating adequately functioning bone marrow (hematology)
Kidney function
Laboratory values demonstrating adequately functioning kidney
Liver function
Laboratory values demonstrating adequately functioning liver
Cardiac function
Adequate heart function as measured by ECHO/MUGA scan
Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology). Adequate heart function as measured by ECHO/MUGA scan.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Hospitals · Ann Arbor, Michigan
- Case Comprehensive Cancer Center · Cleveland, Ohio
- Oregon Health & Science University · Portland, Oregon
- The University of Texas MD Anderson Cancer Center · Houston, Texas
- NEXT Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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