Actively Recruiting
A Study of KC1036 in Patients with Advanced Solid Tumors
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17
207
Participants Needed
3
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of KC1036 in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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; or 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 greater than 12 weeks
- Patients must voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Untreated brain metastases or brain metastases symptoms uncontrolled for more than 4 weeks
- Presence of other types of malignancies
- Abnormalities in hematologic, renal, or hepatic function
- Risk of bleeding
- Gastrointestinal abnormalities
- Cardiovascular or cerebrovascular diseases
- Prior anti-tumor therapies (chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, surgery) within 4 weeks of enrollment
- Unresolved toxicities from prior anti-tumor therapy not resolved to grade 0 or 1 except alopecia
- Participation in other clinical trials within 4 weeks of enrollment
- Recent major surgery, open biopsy, or significant traumatic injury within 4 weeks of enrollment
- History of organ transplant
- Requirement for immunosuppressive agents or systemic/absorbable topical hormone therapy for immunosuppression
- Uncontrolled ongoing or active infection
- Known HIV infection or active hepatitis B or C requiring antiviral treatment
- Pregnant or lactating women or those not using contraception, including men
- Mental or neurological diseases
- Any other metabolic dysfunction, abnormal physical exam, or abnormal lab findings
- Inability to comply with required study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
2
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Actively Recruiting
3
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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