NN3201 for Cancer

Recruiting at 2 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

Trial Summary

What is the purpose of 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.

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.

Research Team

Sunil Sharma, MD

Principal Investigator

Novelty Nobility

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+