Digestive System TumorsPhase 1/2NCT05260385
To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
A Phase 1/2 study testing KC1036 in people with Digestive System Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive System Tumors
- What is being tested?
- KC1036
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 13 sitesChina
- Study dates
- 24 Jan 2022to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Huang Jing, Doctor of Medicine, 010-87788293, huangjingwg@163.com
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu
Hao Jiang
- Recruiting
Chongqing University Three Gorges Hospital
Chongqing
Li Zhang
- Recruiting
Fujian Cancer Hospital
Fujian
Wu Zhuang
- Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Henan
Ning Li
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Henan
Liuzhong Yang
- Recruiting
Hubei Cancer Hospital
Hubei
Huiting Xu
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technologe
Hubei
Tao Zhang
- Recruiting
Shandong Cancer Hospital & Institute
Shandong
Zuoxing Niu
- Recruiting
Shanghai Chest Hospital
Shanghai
Ming Zhang
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen
Ying Wang
- Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjin
Peng Tang
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
Ying Yuan
About this study
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
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.
Read the 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.
- Conditions
- Digestive System Tumors
- Being tested
- KC1036
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
KC1036 are administered orally QD or BID in 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| QD regimen | Experimental | KC1036 was administered orally in 60 mg once daily, 21 days as a cycle. Receives: Drug: KC1036 |
| BID regimen | Experimental | 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 . Receives: Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Measured: approximately 2 year.
Secondary outcomes (8)
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.
Measured: approximately 2 year
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Measured: approximately 2 year.
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.
Measured: approximately 2 year.
Pharmacokinetics (PK) profile: Cmax
Parameters: Peak Plasma Concentration
Measured: approximately 2 year.
Pharmacokinetics (PK) profile: Tmax
Parameters: Time to reach the maximum plasma concentration
Measured: approximately 2 year.
Pharmacokinetics (PK) profile: T1/2
Parameters: Terminal half-life
Measured: approximately of 2 year.
Pharmacokinetics (PK) profile: AUC
arameters: Area under the single-dose plasma concentration-time curve.
Measured: approximately of 2 year.
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: approximately of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start24 Jan 2022
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260385
- Sponsor's protocol ID
- KC1036-II-01
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05260385
- Acronym / sponsor ID
- KC1036-II-01
- Conditions
- Digestive System Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QD regimen | Experimental | Drug: KC1036KC1036 was administered orally in 60 mg once daily, 21 days as a cycle. |
| BID regimen | Experimental | Drug: KC1036Dose-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 . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (14 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC1036KC1036 are administered orally QD or BID in 21-day cycles. | Drug | BID regimen, QD regimen |
Primary outcome
Objective Response Rate (ORR)
Time frame: approximately 2 year.
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
8 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KC1036 in people with Digestive System Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, Medicine Doctor (010-87788293, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: approximately 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.