A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
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
1 other identifier
interventional
67
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 23, 2025
September 1, 2025
2.6 years
January 8, 2025
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with Dose-limiting Toxicities:
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.
3 weeks
Incidence of Adverse Events:
Number of subjects with adverse events (AEs) according to severity, seriousness, and relationship to study drug
1 year
Secondary Outcomes (4)
Choose which dose(s) will be used in the expansion cohorts
1 year
Pharmacokinetics (PK) of NN3201
3 years
Assessment of anti-tumor activity
3 years
Choose which dose(s) may be used in a future study
3 years
Other Outcomes (4)
Immunogenicity against NN3201
3 years
Correlation Between Pharmacokinetic (PK) and Pharmacodynamic (PD) Variables, Safety, and Efficacy
3 yeas
Changes in Biomarker Levels in Response to Treatment
At baseline and specified intervals over 3 years.
- +1 more other outcomes
Study Arms (4)
Part A
EXPERIMENTALNN3201 administered intravenously every three weeks, the dosage to be determined by ascending dose cohort assignment. Part A will enroll patients that have GIST or Other c-Kit tumor disease types. This is an open-label multiple ascending dose study.
Part B, Cohort 1 (GIST)
EXPERIMENTALNN3201 administered intravenously every three weeks, expanding one or two doses in GIST disease type. This is an open-label multiple dose expansion study.
Part B, Cohort 2 (SCLC)
EXPERIMENTALNN3201 administered intravenously every three weeks, expanding one or two doses in SCLC disease type. This is an open-label multiple dose expansion study.
Part B, Cohort 3 (other c-Kit tumors)
EXPERIMENTALNN3201 administered intravenously every three weeks, expanding one or two doses in Other c-Kit tumor disease type. This is an open-label multiple dose expansion study.
Interventions
A c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously.
Eligibility Criteria
You may qualify if:
- Subjects must meet the following criteria to be eligible for enrollment into the study:
- Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.
- Subjects must have received the following treatment:
- Part A (Dose Escalation):
- i. Treatment with imatinib for GIST (at least one line of therapy with imatinib)
- ii. 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)
- Part B (Dose Expansion):
- i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or
- ii. Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or
- iii. Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or 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.
- Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).
- Adequate heart function as measured by ECHO/MUGA scan.
- +9 more criteria
You may not qualify if:
- 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.
- Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).
- Significant cardiovascular impairment.
- Significant screening electrocardiogram (ECG) abnormalities.
- Known active and clinically significant bacterial, fungal, or viral infection.
- Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg, despite optimal medical management.
- Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.
- Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and/or any identified active COVID-19 infection.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
- People who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Michigan Hospitals
Ann Arbor, Michigan, 48109-9001, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Sharma, MD
Novelty Nobility
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
February 3, 2025
Study Start
February 3, 2025
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share