Evaluating KC1036 for 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

This study is testing a new drug called KC1036 to see if it can safely help people with advanced digestive system tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 133 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 13 sites (Beijing and 12 other locations)
• Trial ID: NCT05260385 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, tolerability, and pharmacokinetics of KC1036 in patients with advanced recurrent or metastatic digestive system tumors. It consists of two parts: a QD regimen to evaluate the drug's effectiveness at a dose of 60mg daily, and a BID regimen that includes a dose-escalation phase to determine the safety of 20mg, 30mg, and 40mg taken twice daily. Based on the results from the dose-escalation, an appropriate BID regimen will be selected for further evaluation in a dose-expansion phase.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced recurrent, unresectable, or metastatic digestive system tumors who have failed previous treatments.

Not a fit: Patients with central nervous system metastasis, other malignancies, or significant cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced digestive system tumors who have exhausted standard treatments.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced tumors.

Eligibility criteria

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.

Where this trial is running

Beijing and 12 other locations

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• The first affiliated hospital of bengbu medical college — Bengbu, China (Recruiting)
• Chongqing University Three Gorges Hospital — Chongqing, China (Recruiting)
• Fujian Cancer Hospital — Fujian, China (Recruiting)
• Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Henan, China (Recruiting)
• Hubei Cancer Hospital — Hubei, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technologe — Hubei, China (Recruiting)
• Shandong Cancer Hospital & Institute — Shandong, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center — Shenzhen, China (Recruiting)
• Tianjin Medical University Cancer Institute &Hospital — Tianjin, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jing Huang, Medicine Doctor

Conditions Digestive System Tumors