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NCT06394713 | Not yet recruiting | Advanced Malignant Neoplasm

A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
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.

Condition or disease

Advanced Malignant Neoplasm

Intervention/treatment

QLF31907

Irinotecan

Docetaxel

Phase

Phase 1

Phase 2

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : June 15, 2024
Estimated Primary Completion Date : June 15, 2025
Estimated Study Completion Date : December 15, 2026
Arm Intervention/treatment

Experimental: QLF31907 in combination with Irinotecan

Drug: QLF31907

Drug: Irinotecan

Experimental: QLF31907 in combination with Docetaxel

Drug: QLF31907

Drug: Docetaxel
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

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A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

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