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Trial Title:
A Study of Intratumoral KL340399 in Patients With Advanced Solid Tumors
NCT ID:
NCT05549804
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KL340399 Intratumoral
Description:
KL340399 is a STING-activating. The strength of KL340399 is 0.2 mg/vial or 0.2 mg/vial.
Arm group label:
Dose Escalation
Summary:
This is a single center, open-label, dose increasing study to evaluate the safety,
tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399
intratumoral in patients with advanced solid tumors.
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
intratumoral in patients with advanced solid tumors.The dose increasing method of "BLRM"
is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient is at least ≥18 years of age (male or female);
2. 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 for intratumoral ;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, estimated survival ≥ 3
months;
4. Adequate organ and bone marrow function (no blood components and cytokines are
allowed within 14 days prior to the first dose) ;
5. 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;
6. Patients of childbearing potential (male or female) must use effective medical
contraception during the study and for 3 months after the end of dosing;
7. Patients voluntarily participate in the study, sign the ICF, and will be able to
comply with the protocol-specified visits and relevant procedures.
Exclusion Criteria:
1. Known history of severe allergies, or allergy to any component of KL340399;
2. Received any previous therapy of STING-activating, or received any immunostimulant
therapy within 28 days;
3. Have other malignancies within 5 years;
4. Concomitant or known metastases to brain or central nervous system;
5. Active autoimmune disease;
6. History of major cardiovascular diseases;
7. Uncontrolled systemic diseases;
8. Known of coagulation disorders, hemorrhagic disease;
9. Confirmed serious lung disease or lung disease;
10. Subjects with third space fluid that can not be controled by drainage or other
methods;
11. Known active infection;
12. Known HIV, active hepatitis B/C virus;
13. Pregnant or lactating women;
14. Received immunotherapy and had immune related adverse reactions ≥ grade 3;
15. Have received stem cell transplantation or organ transplantation;
16. Receive any live or attenuated live vaccine within 4 weeks;
17. History of serious dementia, altered mental status, or any psychiatric disorder;
18. Evidence of alcohol or drug abuse;
19. Participated in any other clinical trials and received treatment within 4 weeks;
20. Have other factors based on which the investigator considers that the subjects are
not appropriate to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Dr.
Phone:
010-88196317
Investigator:
Last name:
Jun Guo, Dr.
Email:
Principal Investigator
Start date:
August 30, 2022
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Agency class:
Industry
Source:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549804
