Gastrointestinal Stromal TumorsPhase 1NCT06805825
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 study testing NN3201 in people with Gastrointestinal Stromal Tumors and Small-cell Lung Cancer, run by Novelty Nobility, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma
- What is being tested?
- NN3201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Feb 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- Treatment with imatinib for GIST (at least one line of therapy with imatinib)
- or
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- 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):
- Treatment with imatinib for GIST (at least one line of therapy with imatinib) or
- Progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or
- 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.
- 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 subjects of childbearing potential)
- 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.
- Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
University of Michigan Hospitals
Ann Arbor, Michigan, 48109-9001
Rashmi Chugh, MD, 734-709-2415, rashmim@med.umich.edu
Cancer Answer Line, 800-865-1125, CancerAnswerLine@med.umich.edu
- Recruiting
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Ankit Mangla, MD
(216) 844-3951, ankit.mangla@uhhospitals.org
- Active, not recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dr. Jordi Rodon Ahnert, MD, PhD, 713-792-5603, JRodon@MDAnderson.org
Vu Uyen, 713-794-1254, UMVu@mdanderson.org
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Michael Heinrich, MD, 503-220-3405, heinrich@ohsu.edu
About this study
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
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.
Read the detailed description
The drug being tested in this study is called NN3201, a c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE, administered by IV. The study will be conducted in two parts, a dose escalation phase (Part A) followed by an expansion phase (Part B).
The patient population for the dose escalation phase (Part A) of the study will include patients with advanced and/or metastatic c-Kit-associated solid tumors including gastrointestinal stromal tumor (GIST), adenoid cystic carcinoma (ACC), uveal melanoma, neuroendocrine tumors (NET), and chromophobe and clear cell renal cell carcinomas (ChRCC and ccRCC). For Part A patients must have received treatment with imatinimb for GIST or be progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for cKit-associated solid tumors (ACC, uveal melanoma, NET, ChRCC, or ccRCC). The primary objective of the dose escalation phase (Part A) is to determine the safety profile of NN3201 administered by IV, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limited toxicities (DLTs) as well as the incidence of abnormal laboratory findings and abnormal vital signs. Part A will help determine the maximum tolerated dose (MTD) and/or the recommended dose(s) (RDEs) for the expansion phase (Part B).
Once a recommended dose has been determined in the escalation phase (Part A), the expansion phase (Part B) will assess the safety and efficacy of NN3201 when administered at 2 RDE dose levels to subjects in two indication-specific (GIST and SCLC) expansion cohorts and one basket cohort for c-Kit positive solid tumors (excluding GIST and SCLC). All cohorts in Part B will utilize the same eligibility criteria as in Part A.
Cohort B1 - GIST: up to 10 subjects with GIST will be enrolled at the MTD level (RDE1) and efficacy and safety as well as any available PK and PD data will be evaluated.
Cohort B2 - SCLC: up to 10 SCLC will be enrolled at 1 dose level below MTD (MTD-1/RDE2) and efficacy and safety as well as any available PK and PD data will be evaluated. The Scientific Review Committee (SRC) may decide to enroll and additional 10 subjects in SCLC subjects.
Cohort B3 - c-Kit-associated solid tumors: in this basket cohort, up to 10 subjects with any c-Kit-associated solid tumor (including ACC, uveal melanoma, NET, ChRCC, and ccRCC and excluding GIST and SCLC) will be enrolled.
The safety and tolerability of NN3201 administered intravenously (IV) at up to two RDEs in subjects with advanced and/or metastatic solid tumors is the primary objective for Part B.
- Conditions
- Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma, Uveal Melanoma, Neuroendocrine Tumors, Chromophobe Renal Cell Carcinoma
- Being tested
- NN3201
- Keywords
- GIST, SCLC, ACC, NET, ChRCC, ccRCC, Novelty Nobility, cKit, c-kit, Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma, Uveal Melanoma, Neuroendicrine Tumors, Chromophobe Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, advanced GIST, advanced SCLC, advanced ACC, advanced NET
- Medical subject headings
- Gastrointestinal Stromal Tumors, Small Cell Lung Carcinoma, Carcinoma, Adenoid Cystic, Uveal Melanoma, Neuroendocrine Tumors, Carcinoma, Renal Cell, Piebaldism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NN3201Drug
A c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | 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. Receives: Drug: NN3201 |
| Part B, Cohort 1 (GIST) | Experimental | NN3201 administered intravenously every three weeks, expanding one or two doses in GIST disease type. This is an open-label multiple dose expansion study. Receives: Drug: NN3201 |
| Part B, Cohort 2 (SCLC) | Experimental | NN3201 administered intravenously every three weeks, expanding one or two doses in SCLC disease type. This is an open-label multiple dose expansion study. Receives: Drug: NN3201 |
| Part B, Cohort 3 (other c-Kit tumors) | Experimental | 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. Receives: Drug: NN3201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Incidence of Adverse Events:
Number of subjects with adverse events (AEs) according to severity, seriousness, and relationship to study drug
Measured: 1 year
Secondary outcomes (4)
Choose which dose(s) will be used in the expansion cohorts
Assessing which dose(s) have anti-tumor benefit and an acceptable incidence of adverse events that allow for continued enrollment
Measured: 1 year
Pharmacokinetics (PK) of NN3201
Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints
Measured: 3 years
Assessment of anti-tumor activity
Assessment of anti-tumor activity by RECIST 1.1
Measured: 3 years
Choose which dose(s) may be used in a future study
Assessing which dose(s) have anti-tumor benefit and an acceptable incidence of adverse events that may be used in a future study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start3 Feb 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novelty Nobility, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil Sharma, MD, Principal investigator, Novelty Nobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805825
- Sponsor's protocol ID
- NN3201-ST100
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06805825
- Acronym / sponsor ID
- NN3201-ST100
- Conditions
- Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma, Uveal Melanoma, Neuroendocrine Tumors, Chromophobe Renal Cell Carcinoma
- Keywords
- GIST, SCLC, ACC, NET, ChRCC, ccRCC, Novelty Nobility, cKit
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Novelty Nobility, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study is called NN3201, a c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE, administered by IV. The study will be conducted in two parts, a dose escalation phase (Part A) followed by an expansion phase (Part B).
The patient population for the dose escalation phase (Part A) of the study will include patients with advanced and/or metastatic c-Kit-associated solid tumors including gastrointestinal stromal tumor (GIST), adenoid cystic carcinoma (ACC), uveal melanoma, neuroendocrine tumors (NET), and chromophobe and clear cell renal cell carcinomas (ChRCC and ccRCC). For Part A patients must have received treatment with imatinimb for GIST or be progressive/refractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for cKit-associated solid tumors (ACC, uveal melanoma, NET, ChRCC, or ccRCC). The primary objective of the dose escalation phase (Part A) is to determine the safety profile of NN3201 administered by IV, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limited toxicities (DLTs) as well as the incidence of abnormal laboratory findings and abnormal vital signs. Part A will help determine the maximum tolerated dose (MTD) and/or the recommended dose(s) (RDEs) for the expansion phase (Part B).
Once a recommended dose has been determined in the escalation phase (Part A), the expansion phase (Part B) will assess the safety and efficacy of NN3201 when administered at 2 RDE dose levels to subjects in two indication-specific (GIST and SCLC) expansion cohorts and one basket cohort for c-Kit positive solid tumors (excluding GIST and SCLC). All cohorts in Part B will utilize the same eligibility criteria as in Part A.
Cohort B1 - GIST: up to 10 subjects with GIST will be enrolled at the MTD level (RDE1) and efficacy and safety as well as any available PK and PD data will be evaluated.
Cohort B2 - SCLC: up to 10 SCLC will be enrolled at 1 dose level below MTD (MTD-1/RDE2) and efficacy and safety as well as any available PK and PD data will be evaluated. The Scientific Review Committee (SRC) may decide to enroll and additional 10 subjects in SCLC subjects.
Cohort B3 - c-Kit-associated solid tumors: in this basket cohort, up to 10 subjects with any c-Kit-associated solid tumor (including ACC, uveal melanoma, NET, ChRCC, and ccRCC and excluding GIST and SCLC) will be enrolled.
The safety and tolerability of NN3201 administered intravenously (IV) at up to two RDEs in subjects with advanced and/or metastatic solid tumors is the primary objective for Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: NN3201NN3201 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) | Experimental | Drug: NN3201NN3201 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) | Experimental | Drug: NN3201NN3201 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) | Experimental | Drug: NN3201NN3201 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- or
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NN3201A c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously. | Drug | Part A, Part B, Cohort 1 (GIST), Part B, Cohort 2 (SCLC), Part B, Cohort 3 (other c-Kit tumors) |
Primary outcome
Number of subjects with Dose-limiting Toxicities:
Time frame: 3 weeks
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.
Incidence of Adverse Events:
Time frame: 1 year
Number of subjects with adverse events (AEs) according to severity, seriousness, and relationship to study drug
4 secondary outcomes
Choose which dose(s) will be used in the expansion cohorts
Time frame: 1 year
Pharmacokinetics (PK) of NN3201
Time frame: 3 years
Assessment of anti-tumor activity
Time frame: 3 years
Choose which dose(s) may be used in a future study
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunil Sharma, MD principal investigator
Novelty Nobility
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NN3201 in people with Gastrointestinal Stromal Tumors and Small-cell Lung Cancer, run by Novelty Nobility, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Lead (1 617.870.7173, NN3201@noveltynobility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Dose-limiting Toxicities: (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.