A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.

Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).

Inclusion criteria

(partial):

• Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
• At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
• Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable
• Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable

• Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment
• Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study
• Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation

Exclusion criteria

(partial):

• Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
• History or evidence of suspicious leptomeningeal disease
• Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
• Indwelling percutaneous drainage of bile and chest tube
• Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks