Status:
COMPLETED
A Study of KL340399 in Patients With Advanced Solid Tumors
Lead Sponsor:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 injection in patients with advanced sol...
Detailed Description
This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 injection in patients with advanced sol...
Eligibility Criteria
Inclusion
- Patient is at least ≥18 years of age (male or female);
- Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, estimated survival ≥ 3 months;
- Adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ;
- More than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or CTCAE≤ grade 1;
- Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing;
- Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Exclusion
- Known history of severe allergies, or allergy to any component of KL340399;
- Received any previous therapy of STING-activating, or received any immunostimulant therapy within 28 days；
- Have other malignancies within 5 years;
- Concomitant or known metastases to brain or central nervous system;
- Active autoimmune disease;
- History of major cardiovascular diseases;
- Uncontrolled systemic diseases；
- Known of coagulation disorders, hemorrhagic disease;
- Confirmed serious lung disease or lung disease;
- Subjects with third space fluid that can not be controled by drainage or other methods;
- Known active infection;
- Known HIV, active hepatitis B/C virus;
- Pregnant or lactating women;
- Received immunotherapy and had immune related adverse reactions ≥ grade 3;
- Have received stem cell transplantation or organ transplantation;
- Receive any live or attenuated live vaccine within 4 weeks;
- History of serious dementia, altered mental status, or any psychiatric disorder;
- Evidence of alcohol or drug abuse;
- Participated in any other clinical trials and received treatment within 4 weeks;
- Have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05387928
Start Date
June 7 2022
End Date
April 2 2025
Last Update
December 5 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142