A Study of KC1036 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    207
  • sponsor
    Beijing Konruns Pharmaceutical Co., Ltd.
Updated on 22 August 2021

Summary

The purpose of this study is to evaluate the safetytolerability, 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.

Details
Condition Advanced Solid Tumors
Treatment KC1036
Clinical Study IdentifierNCT04387916
SponsorBeijing Konruns Pharmaceutical Co., Ltd.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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 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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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