NN3201 for Cancer

Recruiting at 6 trial locations

Overseen By Clinical Trial Lead

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novelty Nobility, Inc.

Must be taking: Imatinib

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Brain metastases, Cardiovascular impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and tolerability of NN3201, a potential cancer drug, for individuals with advanced solid tumors containing the c-Kit protein. The trial includes various parts, examining the drug in conditions such as GIST (a type of stomach tumor), small cell lung cancer, and other c-Kit related tumors. It is open to those whose cancer has worsened despite standard treatments or who cannot tolerate or choose to skip existing options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires a 'washout' period (time without taking certain medications) for previous cancer treatments before starting NN3201. This includes at least 21 days for cytotoxic chemotherapy, 14 days for non-cytotoxic chemotherapy, 6 weeks for nitrosoureas, and 28 days for monoclonal antibodies. You should discuss your current medications with the trial team to see if they need to be paused or adjusted.

Is there any evidence suggesting that NN3201 is likely to be safe for humans?

Research has shown that NN3201, a treatment under study for certain tumors such as GIST (gastrointestinal stromal tumors), other c-Kit tumors, and SCLC (small cell lung cancer), has promising safety results in early studies. For example, animal studies demonstrated that repeated doses were well-tolerated, with no harmful effects observed at certain levels. This suggests NN3201 might be safe for humans, but further research is necessary to confirm this.

NN3201 is currently in early human trials. The primary goal is to assess its safety and how well people can tolerate it. Early trials are crucial as they provide insights into the treatment's safety during its initial testing stages with humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about NN3201 because it offers a new approach to treating certain cancers, like GIST, SCLC, and other c-Kit tumors. Unlike traditional treatments that might rely on surgery, chemotherapy, or radiation, NN3201 is administered intravenously and works by targeting specific proteins involved in tumor growth. This targeted approach could potentially lead to more effective treatment outcomes with fewer side effects. Additionally, the flexible dosing schedule—every three weeks—could provide convenience and better quality of life for patients compared to more frequent treatment regimens.

What evidence suggests that NN3201 might be an effective treatment for advanced solid tumors?

Research has shown that NN3201 may be promising in treating tumors with a protein called c-Kit, which plays a crucial role in cell growth. In early lab studies, NN3201 demonstrated strong effects against tumors, including those in the stomach and lungs. This trial will evaluate NN3201 in different treatment arms: Part A for patients with GIST or other c-Kit tumor types, and Part B with separate cohorts for GIST, other c-Kit tumors, and SCLC. The drug uses a special method to deliver treatment directly to cancer cells. These initial results suggest NN3201 might help shrink tumors and slow cancer progression. However, further studies are needed to confirm these results in people. ^{1 2 3 6 7}

Who Is on the Research Team?

Sunil Sharma, MD

Principal Investigator

Novelty Nobility

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic solid tumors that express c-Kit, such as GIST, SCLC, ACC, uveal melanoma, NETs, ChRCC or ccRCC. Participants must have tried standard treatments without success or be unable to tolerate them. They need good kidney, liver and bone marrow function and a life expectancy of at least 3 months.

Inclusion Criteria

My heart is functioning well, as confirmed by a heart scan.

Agreement to use contraception throughout the study for subjects of childbearing potential

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

People who are pregnant or breastfeeding

I have brain metastases that need treatment.

Significant screening electrocardiogram (ECG) abnormalities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive NN3201 intravenously every three weeks to determine the maximum tolerated dose and recommended dose for expansion

3 weeks

1 visit every 3 weeks (in-person)

Dose Expansion (Part B)

Participants receive NN3201 at recommended dose levels to assess safety and efficacy in specific cohorts

1 year

1 visit every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• NN3201

Trial Overview The trial is testing NN3201's safety and how well it's tolerated in patients with specific types of cancer known to express the protein c-Kit. It's an open-label study which means everyone knows they're getting NN3201.

How Is the Trial Designed?

Group I: Part B, Cohort 3 (other c-Kit tumors) Experimental Treatment 1 Intervention

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.

Group II: Part B, Cohort 2 (SCLC) Experimental Treatment 1 Intervention

NN3201 administered intravenously every three weeks, expanding one or two doses in SCLC disease type. This is an open-label multiple dose expansion study.

Group III: Part B, Cohort 1 (GIST) Experimental Treatment 1 Intervention

NN3201 administered intravenously every three weeks, expanding one or two doses in GIST disease type. This is an open-label multiple dose expansion study.

Group IV: Part A Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Novelty Nobility, Inc.

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06805825

NCT06805825 | A Study of the c-Kit Specific Antibody-Drug ... 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- ...

2. gisttrials.org gisttrials.org/iLRG/details.php?Trial=419

trial detail - GIST clinical trials 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- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40908547/

Preclinical Anti-Tumor Efficacy of a Novel Anti-c-Kit ... NN3201 exhibited significant c-Kit-dependent anti-tumor efficacies in various tumor models, followed by favorable pharmacokinetic and toxicity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06805825?term=AREA%5BConditionSearch%5D(%22Chromophobe%20Renal%20Cell%20Carcinoma%22)&rank=4

A Study of the c-Kit Specific Antibody-Drug Conjugate ... 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- ...

5. researchgate.net researchgate.net/publication/395299997_Preclinical_Anti-Tumor_Efficacy_of_a_Novel_Anti-c-Kit_Antibody_Drug_Conjugate_NN3201_in_c-Kit_Positive_Tumors

Preclinical Anti-Tumor Efficacy of a Novel Anti-c-Kit ... NN3201 exhibited significant c-Kit-dependent anti-tumor efficacies in various tumor models, followed by favorable pharmacokinetic and toxicity ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=f201563e-1bda-495f-9978-fbd18d85466a

NN3201 / Novelty Nobility These data suggest that NN3201 is a ... Preclinical • Acute Myelogenous Leukemia • Breast Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12416134/

Gastrointestinal Stromal Tumor: Current Approaches and ... This review examines the current treatment landscape for advanced GIST, with a focus on emerging therapies and their mechanisms of action. It also explores ...