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A Phase I Study of KC1036 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387916
Recruitment Status : Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing Konruns Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: KC1036 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2023

Arm Intervention/treatment
Experimental: KC1036
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.
Drug: KC1036
Part 1: Dose-escalation phase , KC1036 10mg~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 2~3 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.




Primary Outcome Measures :
  1. 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.

  2. Adverse events (AEs) [ Time Frame: From enrollment up to 30 days after last dose ]
    Incidence of treatment-related AEs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) profile: Cmax [ Time Frame: First 4 weeks after initial administration of KC1036 ]
    Peak Plasma Concentration

  2. Pharmacokinetics (PK) profile: Tmax [ Time Frame: First 4 weeks after initial administration of KC1036 ]
    Time to reach the maximum plasma concentration

  3. Pharmacokinetics (PK) profile: T1/2 [ Time Frame: First 4 weeks after initial administration of KC1036 ]
    Terminal half-life

  4. Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ [ Time Frame: First 4 weeks after initial administration of KC1036 ]
    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

  5. Objective Response Rate (ORR) [ Time Frame: Every 6 weeks for the duration of study participation; estimated to be 12 months ]
    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.

  6. Progression-free survival (PFS) [ Time Frame: Every 6 weeks for the duration of study participation; estimated to be 12 months ]
    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.

  7. Disease Control Rate (DCR) [ Time Frame: Every 6 weeks for the duration of study participation; estimated to be 12 months ]
    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.

  8. Duration of Response (DOR) [ Time Frame: Every 6 weeks for the duration of study participation; estimated to be 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 assessable or measurable lesion (by RECIST 1.1), that can be accurately measured at baseline as ≥ 10mm in the longest diameter or lymph nodes which must have short axis ≥ 15mm with computerised tomography (CT);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387916


Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China
Contact: Junyu Wu, Ph.D    0086-10-53056686 ext 2063    wujy@konruns.cn   
Principal Investigator: Yongsheng Wang, Ph.D         
Principal Investigator: Qiu Li, Ph.D         
Sponsors and Collaborators
Beijing Konruns Pharmaceutical Co., Ltd.
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Responsible Party: Beijing Konruns Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04387916    
Other Study ID Numbers: KC1036-I-01
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms