RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-03

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06805825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC. 2. Subjects must have received the following treatment: 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator. 5. Age ≥ 18 years. 6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology). 7. Adequate heart function as measured by ECHO/MUGA scan. 8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below: 1. Cytotoxic chemotherapy - At least 21 days 2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days 3. Nitrosoureas - At least 6 weeks 4. Monoclonal antibody(ies) - At least 28 days 5. Radiotherapy - At least 14 days from local site radiation therapy 9. Negative Serum/urine pregnancy test (for subjects of childbearing potential) 10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile. 11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.	1. Has received prior therapy with a c-Kit agent (except GIST subjects). 2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. 3. 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). 4. 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. 5. 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). 6. Significant cardiovascular impairment. 7. Significant screening electrocardiogram (ECG) abnormalities. 8. Known active and clinically significant bacterial, fungal, or viral infection. 9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg, despite optimal medical management. 10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening. 11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and/or any identified active COVID-19 infection. 12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study. 13. People who are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

1. Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.
2. Subjects must have received the following treatment:
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.
5. Age ≥ 18 years.
6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).
7. Adequate heart function as measured by ECHO/MUGA scan.
8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:
1. Cytotoxic chemotherapy - At least 21 days
2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days
3. Nitrosoureas - At least 6 weeks
4. Monoclonal antibody(ies) - At least 28 days
5. Radiotherapy - At least 14 days from local site radiation therapy
9. Negative Serum/urine pregnancy test (for subjects of childbearing potential)
10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.
11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.

1. Has received prior therapy with a c-Kit agent (except GIST subjects).
2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
3. 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).
4. 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.
5. 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).
6. Significant cardiovascular impairment.
7. Significant screening electrocardiogram (ECG) abnormalities.
8. Known active and clinically significant bacterial, fungal, or viral infection.
9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg, despite optimal medical management.
10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.
11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and/or any identified active COVID-19 infection.
12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
13. People who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Clinical Trial Lead

CONTACT

1 617.870.7173

NN3201@noveltynobility.com

Principal Investigator

Sunil Sharma, MD

PRINCIPAL_INVESTIGATOR

Novelty Nobility

Study Locations (Sites)

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Novelty Nobility, Inc.

Sunil Sharma, MD, PRINCIPAL_INVESTIGATOR, Novelty Nobility

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2027-12-31

Study Record Updates