Experimental cancer drug injected directly into tumors shows early promise

NCT ID NCT05549804

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a new drug called KL340399, which is injected directly into tumors to activate the immune system. It involved 6 adults with advanced solid tumors who had no other treatment options. The main goals were to check safety, find the right dose, and see if the drug could shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KL340399 (a STING-activating drug injected directly into tumors)
What this could lead to
If it works, this could point toward a new way to treat advanced solid tumors by activating the immune system directly at the tumor site.
What could go wrong
This is a very early, small Phase 1 trial with only 6 patients, focused on safety and dosing. It is too soon to know if it will be effective or safe for broader use.

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

6 people

The number who actually took part.

Started

Aug 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

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

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 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.

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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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