Clinical trial · Interventional
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatic Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SM04755 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SM04755
- interventionNames
- Drug: SM04755
Primary outcomes (1)
- measure
- Determine the MTD
- timeFrame
- 28 days
Secondary outcomes (9)
- measure
- 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
- timeFrame
- 28 days
- measure
- Area under the plasma concentration (AUC) Versus Time Curve of SM04755
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available