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New treatment option for Gastrointestinal Stromal Tumors
Official title A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
ClinicalTrials.gov ID: NCT06805825
What this study is testing
What is NN3201?
NN3201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal stromal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key people 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.
- people must have received the following treatment: Part A (Dose Escalation): i. Treatment with imatinib for GIST (at least one line of therapy with...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.
You likely can't join if
- Has received prior therapy with a c-Kit agent (except GIST people).
- 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...
- Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 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...
- Significant cardiovascular impairment.
See the full eligibility criteria
- Key people 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.
- people 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...
- 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.
- Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:
- Cytotoxic chemotherapy - At least 21 days
- Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days
- Nitrosoureas - At least 6 weeks
- Monoclonal antibody(ies) - At least 28 days
- Radiotherapy - At least 14 days from local site radiation therapy
- Negative Serum/urine pregnancy test (for people of childbearing potential)
- All people of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. people must refrain from donating sperm during the same...
- Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol. Key
- Has received prior therapy with a c-Kit agent (except GIST people).
- 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...
- 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...
- 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. Other inclusion and exclusion criteria must also be met to be eligible to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Cleveland, Ohio, United States; Portland, Oregon, United States; Houston, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.