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New treatment option for Advanced Solid Tumors
Official title A Study of KC1036 in Patients with Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04387916
What this study is testing
What is KC1036?
KC1036 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one measurable lesion (by RECIST 1.1);
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Life expectancy \> 12 weeks;
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Haikou, Hainan, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Haikou, Hainan, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.