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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit (NCT06805825) is a Phase 1 interventional studying Gastrointestinal Stromal Tumors and Small-cell Lung Cancer, sponsored by Novelty Nobility, INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Gastrointestinal Stromal Tumors, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 67 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastrointestinal Stromal Tumors subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: Subjects must meet the following criteria to be eligible for enrollment into the study: 1. diagnosed by tissue sample (biopsy-confirmed) locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC. 2. 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) or 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). 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: Subjects must meet the following criteria to be eligible for enrollment into the study: 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: Part A (Dose Escalation): 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 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). 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. Key Exclusion Criteria: 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. Other inclusion and exclusion criteria must also be met to be eligible to participate in this study.

Treatments Being Tested

DRUG

NN3201

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

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Michigan Hospitals
Ann Arbor, Michigan, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06805825), the sponsor (Novelty Nobility, INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06805825 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06805825?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06805825?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06805825. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06805825. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.