NCT06394713
Not yet recruiting
Phase 1
A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors
ConditionsAdvanced Malignant Neoplasm
Overview
- Phase
- Phase 1
- Intervention
- QLF31907
- Conditions
- Advanced Malignant Neoplasm
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Enrollment
- 60
- Primary Endpoint
- phase Ib: Dose-limiting toxicity(DLT)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
Investigators
Eligibility Criteria
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;
Arms & Interventions
QLF31907 in combination with Irinotecan
Intervention: QLF31907
QLF31907 in combination with Irinotecan
Intervention: Irinotecan
QLF31907 in combination with Docetaxel
Intervention: QLF31907
QLF31907 in combination with Docetaxel
Intervention: Docetaxel
Outcomes
Primary Outcomes
phase Ib: Dose-limiting toxicity(DLT)
Time Frame: 28 days
The DLT of QLF31907 combination therapy will be determined
phase2: objective response rate(ORR)
Time Frame: up to 2 years
the ORR of QLF31907 combinaton therapy will be determined
Secondary Outcomes
- adverse events (AEs) of QLF31907 combination therapy(up to 2 years)
- maximum plasma concentration (Cmax) of QLF31907(up to 2 years)
- Immunogenicity of QLF31907(up to 2 years)
- overall survival(OS)(up to 2 years)
- area under the concentration-time curve (AUC) of QLF31907(up to 2 years)
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