NCT04387916 A Study of KC1036 in Patients with Advanced Solid Tumors
| NCT ID | NCT04387916 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 207 participants |
| Start Date | 2020-09-04 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 207 participants in total. It began in 2020-09-04 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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.
Frequently Asked Questions
Who can join the NCT04387916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04387916 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04387916 currently recruiting?
Yes, NCT04387916 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Konruns Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT04387916 trial being conducted?
This trial is being conducted at Chongqing, China, Haikou, China, Chengdu, China.
Who is sponsoring the NCT04387916 clinical trial?
NCT04387916 is sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. The trial plans to enroll 207 participants.