Advanced Solid TumorsPhase 1NCT04387916
A Study of KC1036 in Patients with Advanced Solid Tumors
A Phase 1 study testing KC1036 in people with Advanced Solid Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid 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
- 207 participants
- Where
- 3 sitesChina
- Study dates
- 4 Sep 2020to 31 Dec 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Junyu Wu, Ph.D, 0086-10-82898888 ext. 6803, wujy@konruns.cn
Yongsheng Wang, Ph.D
- Recruiting
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality
Junyu Wu, ph.D, 0086-10-82898888 ext. 6803, wujy@konruns.cn
Weiqi Nian, ph.D
- Recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Junyu Wu, ph.D, 0086-10-82898888 ext. 6803, wujy@konruns.cn
xinbao Hao, ph.D
About this study
Official title: 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
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
- Advanced Solid Tumors
- Being tested
- KC1036
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
Part 1: Dose-escalation phase , KC1036 10mg~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.
| Study group | Role | What they receive |
|---|---|---|
| KC1036 | Experimental | 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. Receives: Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
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.
Measured: First 4 weeks after initial administration of KC1036
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: From enrollment up to 30 days after last dose
Secondary outcomes (9)
Pharmacokinetics (PK) profile: Cmax
Peak Plasma Concentration
Measured: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: Tmax
Time to reach the maximum plasma concentration
Measured: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: T1/2
Terminal half-life
Measured: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Measured: First 4 weeks after initial administration of KC1036
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: Every 6 weeks for the duration of study participation; estimated to be 12 months
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: Every 6 weeks for the duration of study participation; estimated to be 12 months
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: Every 6 weeks for the duration of study participation; estimated to be 12 months
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: Every 6 weeks for the duration of study participation; estimated to be 12 months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the start date of study drug to the date of death due to any cause.
Measured: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start4 Sep 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 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
- NCT04387916
- Sponsor's protocol ID
- KC1036-I-01
- Status last verified
- Oct 2024
- First submitted
- 11 May 2020
- 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 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
- ClinicalTrials.gov ID
- NCT04387916
- Acronym / sponsor ID
- KC1036-I-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KC1036 | Experimental | Drug: KC1036Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
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 |
|---|---|---|
| KC1036Part 1: Dose-escalation phase , KC1036 10mg~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2. | Drug | KC1036 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: First 4 weeks after initial administration of KC1036
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.
Adverse events (AEs)
Time frame: From enrollment up to 30 days after last dose
Incidence of treatment-related AEs
9 secondary outcomes
Pharmacokinetics (PK) profile: Cmax
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: Tmax
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: T1/2
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞
Time frame: First 4 weeks after initial administration of KC1036
Objective Response Rate (ORR)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Progression-free survival (PFS)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Disease Control Rate (DCR)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Duration of Response (DOR)
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Overall Survival (OS)
Time frame: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]
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.
The First Affiliated Hospital of Hainan Medical University
Haikou, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KC1036 in people with Advanced Solid Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 3 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 18 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 3 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: First 4 weeks after initial administration of KC1036). The study lists 2 primary outcomes in all. 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.