Actively Recruiting
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
Led by Novelty Nobility, Inc. · Updated on 2025-09-23
67
Participants Needed
5
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced, metastatic, or unresectable GIST, SCLC, ACC, uveal melanoma, NET, ChRCC, or ccRCC.
- For Part A, prior treatment with imatinib for GIST or progressive/refractory, ineligible, intolerant to standard therapy, or declined standard therapy for c-Kit solid tumors.
- For Part B, prior treatment with imatinib for GIST; or progressive/refractory, ineligible, intolerant to standard therapy, or declined standard therapy for extensive stage SCLC or c-Kit solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months before starting NN3201.
- Age 18 years or older.
- Adequate kidney, liver, and bone marrow function.
- Adequate heart function by ECHO or MUGA scan.
- Required time intervals between prior anticancer therapies and first NN3201 dose (e.g., 21 days for cytotoxic chemotherapy).
- Negative pregnancy test for subjects of childbearing potential.
- Agreement to use contraception during the study and for 120 days after last dose (if of childbearing potential).
- Willingness and ability to provide informed consent and comply with study procedures.
You will not qualify if you...
- Prior therapy with a c-Kit agent (except for GIST subjects).
- Untreated, symptomatic, or therapy-required brain metastases.
- Need for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressants within 14 days before study drug.
- Unresolved or unstable treatment-related toxicities greater than Grade 1.
- Major surgery within 30 days before first study drug dose (except venous access port placement).
- Significant cardiovascular impairment or abnormal screening ECG.
- Active and clinically significant bacterial, fungal, or viral infections.
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) despite treatment.
- Venous thrombosis or pulmonary embolism within 3 months before screening.
- Active infection requiring IV anti-infective or systemic therapy, including active COVID-19.
- Any other major illness increasing risk of participation as judged by Investigator.
- Pregnancy or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109-9001
Actively Recruiting
2
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Active, Not Recruiting
Research Team
C
Clinical Trial Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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