Clinical trial · Interventional
A Study of KC1036 in Patients with Advanced Solid Tumors
A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors
- 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 safety,tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KC1036 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KC1036
- description
- Patients take a single dose of KC1036 for the pharmacokinetic study, then off for 5 days before the first cycle begins. In the subsequent treatment cycles, KC1036 are given orally once daily, 21 days as a cycle.
- interventionNames
- Drug: KC1036
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- First 4 weeks after initial administration of KC1036
- description
- MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
- measure
- Adverse events (AEs)
- timeFrame
- From enrollment up to 30 days after last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed recurrent or metastatic solid tumors; * Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy: Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy; * At least one measurable lesion (by RECIST 1.1); * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks; * Other kinds of malignancies; * Hematologic, renal, and hepatic function abnormities; * Risk of bleeding; * Gastrointestinal abnormalitiest; * Cardiovascular and cerebrovascular diseases; * Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment; * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia; * Involved in other clinical trials within 4 weeks of enrollment; * Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment; * History of organ allograft; * Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression; * Uncontrolled ongoing or active infection; * Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy; * Pregnant or lactating women or those who do not take contraceptives, including men; * Suffering from mental and neurological diseases; * 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