Advanced Solid TumorsPhase 1NCT05387928
A Study of KL340399 in Patients With Advanced Solid Tumors
A Phase 1 study testing KL340399 injection in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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 solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- KL340399 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2022to 2 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Injection in Patients With Advanced Solid Tumors
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 solid tumors.
Read the 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 solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).
- Conditions
- Advanced Solid Tumors
- Being tested
- KL340399 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL340399 injectionDrug
KL340399 injection is a STING-activating. The strength of KL340399 is 0.2 mg/vial，0.2 mg/vial.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | KL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses. Receives: Drug: KL340399 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Measured: From data of initial dose until up to 21 days for treatment
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) is refers to the highest dose at which the patient's DLT incidence exceeding 33% during the first cycle.
Measured: From data of initial dose until up to 21 days for treatment
Recommended Phase 2 Dose (RP2D)
The recommended phase 2 dose (RP2D) will be based on a consideration of the totality of data including but not limited to safety data (including DLTs), PK, PD and preliminary efficacy, as available.
Measured: Up to 24 months
Incidence of Adverse Events [Safety and Tolerability]
Incidence of adverse events of KL340399 as a monotherapy as determined by patient reporting, clinical laboratory test changes from baseline, and clinically significant changes in physical examination data.
Measured: Up to 24 months
Secondary outcomes (4)
Objective Response Rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Measured: Up to 24 months
Progression Free Survival (PFS)
PFS: Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Measured: Up to 24 months
Duration of Response (DOR)
DOR: Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Measured: Up to 24 months
Overall Survival (OS)
OS: Time from start of treatment to death due to any reason.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start7 Jun 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Dr., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387928
- Sponsor's protocol ID
- KL296-I-01
- Status last verified
- May 2026
- First submitted
- 19 May 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05387928
- Acronym / sponsor ID
- KL296-I-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 injection 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: KL340399 injectionKL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL340399 injectionKL340399 injection is a STING-activating. The strength of KL340399 is 0.2 mg/vial，0.2 mg/vial. | Drug | Dose Escalation |
Primary outcome
Number of subjects achieving Dose-limiting toxicity (DLT)
Time frame: From data of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Maximum Tolerated Dose (MTD)
Time frame: From data of initial dose until up to 21 days for treatment
The maximum tolerated dose (MTD) is refers to the highest dose at which the patient's DLT incidence exceeding 33% during the first cycle.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 24 months
The recommended phase 2 dose (RP2D) will be based on a consideration of the totality of data including but not limited to safety data (including DLTs), PK, PD and preliminary efficacy, as available.
Incidence of Adverse Events [Safety and Tolerability]
Time frame: Up to 24 months
Incidence of adverse events of KL340399 as a monotherapy as determined by patient reporting, clinical laboratory test changes from baseline, and clinically significant changes in physical examination data.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo, Dr. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KL340399 injection in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects achieving Dose-limiting toxicity (DLT) (time frame: From data of initial dose until up to 21 days for treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.