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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Novelty Nobility, Inc.
Study ID
NCT06805825
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NN3201 — DRUG
    A c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously.

Study Details

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.

Key Dates

First listed
Feb 3, 2025
Start date
Feb 3, 2025
Status verified
Sep 2025
Primary completion
Aug 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
67 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    NN3201 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.
  • Experimental: Part B, Cohort 1 (GIST)
    NN3201 administered intravenously every three weeks, expanding one or two doses in GIST disease type. This is an open-label multiple dose expansion study.
  • Experimental: Part B, Cohort 2 (SCLC)
    NN3201 administered intravenously every three weeks, expanding one or two doses in SCLC disease type. This is an open-label multiple dose expansion study.
  • Experimental: Part B, Cohort 3 (other c-Kit tumors)
    NN3201 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.

Primary Outcome Measure

Number of subjects with Dose-limiting Toxicities: [ Time Frame: 3 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Michigan HospitalsAnn ArborMichigan48109-9001
Rashmi Chugh, MD
[email protected]
734-709-2415
Cancer Answer Line
[email protected]
800-865-1125
Case Comprehensive Cancer CenterClevelandOhio44106
Ankit Mangla, MD
[email protected]
(216) 844-3951
Oregon Health & Science UniversityPortlandOregon97239
Michael Heinrich, MD
[email protected]
503-220-3405
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Dr. Jordi Rodon Ahnert, MD, PhD
[email protected]
713-792-5603
Vu Uyen
[email protected]
713-794-1254
NEXT VirginiaFairfaxVirginia22031-

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By specialty
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By research site
University of Michigan Hospitals· Ann Arbor, MICase Comprehensive Cancer Center· Cleveland, OHOregon Health & Science University· Portland, ORThe University of Texas MD Anderson Cancer Center· Houston, TXNEXT Virginia· Fairfax, VA

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