A Study of Intratumoral KL340399 in Patients With Advanced Solid Tumors

NCT05549804 | Completed Phase 1

• 1 other identifier: KL296-I-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

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

• 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.

  Up to 24 months

• 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.

  Up to 24 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Duration of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Dose Escalation

EXPERIMENTAL

KL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses.

Drug: KL340399 Intratumoral

Interventions

KL340399 Intratumoral DRUG

KL340399 is a STING-activating. The strength of KL340399 is 0.2 mg/vial or 0.2 mg/vial.

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

• Jun Guo, Dr.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: August 30, 2022
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (1)