Experimental cancer drug KL340399 tested in 21 patients
NCT ID NCT05387928
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called KL340399 in 21 adults with advanced solid tumors that had stopped responding to standard treatments. The drug works by activating the STING pathway to help the immune system fight cancer. The main goals were to check safety, find the right dose, and see early signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KL340399 injection (a STING-activating drug)
- What this could lead to
- If this works, it could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and dosing, not on proving effectiveness. The drug may not shrink tumors or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
-
Apr 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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