Clinical trial · Interventional
To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors
NCT05260385CI-TRIAL-00081681recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KC1036 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QD regimen
- description
- KC1036 was administered orally in 60 mg once daily, 21 days as a cycle.
- interventionNames
- Drug: KC1036
- type
- EXPERIMENTAL
- label
- BID regimen
- description
- Dose-Escalation part : KC1036 was administered orally in 20 mg BID, 30 mg BID, or 40 mg BID. Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion .
- interventionNames
- Drug: KC1036
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed malignant digestive system tumors; * Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment); * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * BMI≥18.0; * Has adequate Hematologic, renal, and hepatic function; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms; * Other kinds of malignancies; * Gastrointestinal abnormalitiest; * Cardiovascular and cerebrovascular diseases; * Previous treatment with small molecule vascular targeting inhibitor; * Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment; * Involved in other clinical trials within 4 weeks before enrollment; * Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment; * Uncontrolled massive ascites,pleural/pericardial effusion; * Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (\> 38.5 ℃) occurred within 2 weeks before enrollment; * Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ; * Pregnant or lactating women or those who do not take contraceptives, including men; * Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings; * Inability to comply with protocol required procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.