A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
Phase 1
Not yet recruiting
- Conditions
- Advanced Malignant Neoplasm
- Interventions
- Registration Number
- NCT06394713
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- subjects voluntarily participated and signed a written informed consent form;
- age ≥18 years, male or female;
- ECOG PS 0-1;
- histopathologically diagnosed advanced malignant tumors;
- at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
- adequate organ function;
Exclusion Criteria
- previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
- received anti-tumor therapy within 4 weeks prior to the first study treatment;
- history of autoimmune disease;
- history of other active malignancies within 3 years prior to the first treatment;
- history of serous cardiovascular events;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description QLF31907 in combination with Irinotecan QLF31907 - QLF31907 in combination with Docetaxel QLF31907 - QLF31907 in combination with Irinotecan Irinotecan - QLF31907 in combination with Docetaxel Docetaxel -
- Primary Outcome Measures
Name Time Method phase Ib: Dose-limiting toxicity(DLT) 28 days The DLT of QLF31907 combination therapy will be determined
phase2: objective response rate(ORR) up to 2 years the ORR of QLF31907 combinaton therapy will be determined
- Secondary Outcome Measures
Name Time Method adverse events (AEs) of QLF31907 combination therapy up to 2 years to evaluate the severity, incidence and causality of adverse events (AEs)
maximum plasma concentration (Cmax) of QLF31907 up to 2 years the maximum plasma concentration (Cmax) of QLF31907 will be determined
Immunogenicity of QLF31907 up to 2 years the anti-drug antibody(ADA) against QLF31907 will be determined
overall survival(OS) up to 2 years the OS of QLF31907 combination therapy will be determined
area under the concentration-time curve (AUC) of QLF31907 up to 2 years the area under the concentration-time curve (AUC) of QLF31907 will be determined