Actively Recruiting
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
Led by Novelty Nobility, Inc. · Updated on 2025-09-23
67
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of NN3201, a c-Kit targeting antibody-drug conjugate, in adults with advanced or metastatic solid tumors that express c-Kit. This includes cancers such as gastrointestinal stromal tumor (GIST), adenoid cystic carcinoma, uveal melanoma, neuroendocrine tumors, and certain types of renal cell carcinoma. The study is an open-label Phase 1 trial designed to identify the safest dose and assess how well patients tolerate the treatment. The study is divided into two parts: a dose escalation phase (Part A) and an expansion phase (Part B). In Part A, NN3201 is given intravenously every three weeks to patients with GIST or other c-Kit tumor types at increasing doses to determine the maximum tolerated dose. Once the optimal dose is established, Part B will enroll patients into three groups based on their cancer type—GIST, small-cell lung cancer (SCLC), and other c-Kit positive tumors—to further evaluate safety and early signs of effectiveness, with treatment continuing every three weeks at one or two recommended dose levels. Participants will undergo regular assessments including monitoring for side effects, laboratory tests to check organ function, heart scans, and evaluations of tumor response. Researchers will closely track adverse events and dose-limiting toxicities during the study. The primary outcomes include safety measures such as the number of patients experiencing dose-limiting toxicities within three weeks and adverse events over one year. The study may last up to several years to gather pharmacokinetic data and assess anti-tumor activity, with participant involvement spanning the treatment and follow-up periods as defined by the protocol.
CONDITIONS
Brief 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, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET, ChRCC, or ccRCC.
- For Part A: treatment with imatinib for GIST or progressive/refractory, ineligible, intolerant, or declined standard therapy for other c-Kit-associated tumors.
- For Part B: treatment with imatinib for GIST, or progressive/refractory, ineligible, intolerant, or declined standard therapy for extensive stage SCLC or other c-Kit-associated tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months as judged by the investigator.
- Age 18 years or older.
- Adequate kidney, liver, and bone marrow function.
- Adequate heart function as measured by ECHO/MUGA scan.
- Sufficient time since prior anticancer therapies as specified (e.g., at least 21 days after 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, or confirmed post-menopausal or sterile.
- Voluntary written informed consent and willingness to comply with study requirements.
You will not qualify if you...
- Prior therapy with a c-Kit agent (except for GIST subjects).
- Untreated, symptomatic, or uncontrolled brain metastases.
- Need for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressive medications within 14 days before study drug administration (inhaled steroids allowed).
- Unresolved or unstable treatment-related toxicities greater than Grade 1.
- Major surgery within 30 days before first dose (excluding port placement).
- Significant cardiovascular impairment or ECG abnormalities.
- Active and significant bacterial, fungal, or viral infection.
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) despite treatment.
- Venous thrombosis or pulmonary embolism within the last 3 months.
- Active infection requiring intravenous anti-infective therapy or active COVID-19 infection.
- Any major illness increasing risk of participation as judged by the investigator.
- Pregnant or breastfeeding individuals.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation.
Participants receive NN3201 intravenously every three weeks in dose escalation or expansion cohorts depending on their tumor type and dose assignment.
Visits every three weeks for infusions
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here