Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

Study Overview
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Brief Summary
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This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.

Official Title
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Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

Conditions
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Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: SM04755


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy Subjects must meet certain laboratory criteria Expected survival > 3months Subjects must have no uncontrolled intercurrent illness Exclusion Criteria: Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method Subjects with significant cardiac issues Subjects using certain medications Subjects with certain medical conditions Subjects with brain metastasis Subjects who have recently been enrolled in other experimental clinical trials of investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SM04755<br> | Drug: SM04755<br>* Escalating Doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the MTD |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings |  | 28 days | 
| Area under the plasma concentration (AUC) Versus Time Curve of SM04755 |  | 30 days | 
| Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST) |  | 8 weeks | 
| Maximum Observed Plasma Concentration (Cmax) of SM04755 |  | 30 Days | 
| Half Life of SM04755 |  | 30 Days | 
| Volume of Distribution of SM04755 |  | 30 Days | 
| Time to maximum plasma concentration |  | 30 Days | 
| Accumulation ratio of SM04755 |  | 30 Days | 
| Total Clearance of SM04755 after oral administration |  | 30 days |