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Recruiting NCT05260385

To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

Phase I / Phase II Interventional Digestive System Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KC1036.
Who it may be relevant to
Registry conditions: Digestive System Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors

Overview

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.

Detailed description

This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen.

The study will consist of two parts:

Part 1: QD regimen

To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen.

Part 2: BID regimen

Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors.

Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.

Interventions

  • Drug KC1036
    KC1036 are administered orally QD or BID in 21-day cycles.

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: approximately 2 year.]
Secondary outcome measures (8)
  • Progression-free survival (PFS) [Time frame: approximately 2 year]
  • Disease Control Rate (DCR) [Time frame: approximately 2 year.]
  • Duration of Response (DOR) [Time frame: approximately 2 year.]
  • Pharmacokinetics (PK) profile: Cmax [Time frame: approximately 2 year.]
  • Pharmacokinetics (PK) profile: Tmax [Time frame: approximately 2 year.]
  • Pharmacokinetics (PK) profile: T1/2 [Time frame: approximately of 2 year.]
  • Pharmacokinetics (PK) profile: AUC [Time frame: approximately of 2 year.]
  • Adverse events (AEs) [Time frame: approximately of 2 year.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
  • The first affiliated hospital of bengbu medical college — Bengbu
  • Chongqing University Three Gorges Hospital — Chongqing
  • Fujian Cancer Hospital — Fujian
  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Henan
  • The First Affiliated Hospital of Xinxiang Medical University — Henan
  • Hubei Cancer Hospital — Hubei
  • Union Hospital Tongji Medical College Huazhong University of Science and Technologe — Hubei
  • … and 5 more centers

Identifiers

NCT: NCT05260385 · KC1036-II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗