A Study of KL340399 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: KL340399 injection

• Registration Number: NCT05387928
• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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 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 Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-06-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation	KL340399 injection	KL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	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)	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]	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.
Number of subjects achieving Dose-limiting toxicity (DLT)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to 24 months	DOR: Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Overall Survival (OS)	Up to 24 months	OS: Time from start of treatment to death due to any reason.
Objective Response Rate (ORR)	Up to 24 months	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.
Progression Free Survival (PFS)	Up to 24 months	PFS: Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China