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.
Histologically or cytologically confirmed locally advanced, metastatic, and/or unresectable GIST, SCLC, ACC, uveal melanoma, NET 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.
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.
Sequential
NN3201
DrugA c-Kit targeting fully human monoclonal antibody-drug conjugate with MMAE administered intravenously.
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.
Incidence of Adverse Events:
Number of subjects with adverse events (AEs) according to severity, seriousness, and relationship to study drug
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
Pharmacokinetics (PK) of NN3201
Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints
Assessment of anti-tumor activity
Assessment of anti-tumor activity by RECIST 1.1
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.
Immunogenicity against NN3201
Immunogenicity against NN3201 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies
Correlation Between Pharmacokinetic (PK) and Pharmacodynamic (PD) Variables, Safety, and Efficacy
Evaluation of the correlation between PK parameters (e.g., Cmax, AUC) and PD effects (e.g., changes in target biomarkers), and their relationship to safety outcomes (e.g., incidence of adverse events) and efficacy outcomes (e.g., objective response rate and progression-free survival).
Changes in Biomarker Levels in Response to Treatment
Investigation of changes in specific biomarkers (e.g., soluble c-Kit) during treatment to assess their relationship to treatment response.
Correlation Between Baseline Biomarker Levels and Clinical Response/Toxicity
Assessment of the relationship between baseline levels of specific biomarkers (e.g., soluble c-Kit, tumor c-Kit expression) and clinical outcomes, including response to treatment and incidence of toxicity.
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