CompletedPhase 1

A Study of Intratumoral KL340399 in Patients With Advanced Solid Tumors

China6 participantsStarted 2022-08-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 for intratumoral ;
✓. 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 criteria

✕. 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;

What they're measuring

Number of subjects achieving Dose-limiting toxicity (DLT)

Timeframe: From data of initial dose until up to 21 days for treatment

Maximum Tolerated Dose (MTD)

Timeframe: From data of initial dose until up to 21 days for treatment

Incidence of Adverse Events [Safety and Tolerability]

Timeframe: Up to 24 months

Recommended Phase 2 Dose (RP2D)

Timeframe: Up to 24 months

Trial details

NCT IDNCT05549804

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-21

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 for intratumoral ;
✓. 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 criteria

✕. 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;

What they're measuring

Number of subjects achieving Dose-limiting toxicity (DLT)

Timeframe: From data of initial dose until up to 21 days for treatment

Maximum Tolerated Dose (MTD)

Timeframe: From data of initial dose until up to 21 days for treatment

Incidence of Adverse Events [Safety and Tolerability]

Timeframe: Up to 24 months

Recommended Phase 2 Dose (RP2D)

Timeframe: Up to 24 months