A Study of QLF3108 in Participants With Advanced Solid Tumor

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.

Detailed Description
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This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.

Official Title
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A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: QLF3108


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial. ≥18 years old and body weight ≥40 kg; Female or male. Histologically or cytologically documented advanced solid tumor; Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors. Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1. Life expectancy of at least 12 weeks. Adequate hematologic and end organ function. Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study. Exclusion Criteria: Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug. Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug. Active autoimmune disease that has required systemic treatment within 2 years prior to this study. A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug. Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status. Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period. Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation). Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study. Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-Escalation Stage and PK-Expansion Stage<br>Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD). PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial. | Drug: QLF3108<br>* QLF3108 will be administered independent of body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLTs of QLF3108 | dose-limiting toxicity | Approximately 24 months | 
| MTD(s) of QLF3108 | the maximum tolerated dose | Approximately 24 months | 
| RP2D of QLF3108 | a recommended Phase 2 dose | Approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0 | The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0 | Approximately 24 month | 
| The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0 | The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0 | Approximately 24 month | 
| Cmax of QLF3108 | Pharmacokinetics of QLF3108 by assessment of maximum plasma QLF3108 concentration. | Approximately 24 month | 
| Tmax of QLF3108 | Pharmacokinetics of QLF3108 by assessment of time to Cmax | Approximately 24 month | 
| Area under the plasma concentration-time curve (AUC) of QLF3108 | Pharmacokinetics of QLF3108 by assessment of area under the plasma concentration time curve from zero to infinity | Approximately 24 month | 
| Tl/2 of QLF3108 | Pharmacokinetics of QLF3108 by assessment of the terminal half-life | Approximately 24 month | 
| Overall Response Rate (ORR) | ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Approximately 24 months | 
| Duration of Response (DOR) | DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 | Approximately 24 months | 
| Progression-free survival (PFS) | PFS defined as the time from baseline to first observed disease progression or death from any cause | Approximately 24 months | 
| Overall survival time (OS) | Overall survival (OS) is the time between the subject's first infusion QLF3108 injection and death from any cause. | Approximately 24 months |