A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
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
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2024
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
June 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
ExpectedMay 1, 2024
April 1, 2024
1 year
April 22, 2024
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
phase Ib: Dose-limiting toxicity(DLT)
The DLT of QLF31907 combination therapy will be determined
28 days
phase2: objective response rate(ORR)
the ORR of QLF31907 combinaton therapy will be determined
up to 2 years
Secondary Outcomes (5)
adverse events (AEs) of QLF31907 combination therapy
up to 2 years
area under the concentration-time curve (AUC) of QLF31907
up to 2 years
Immunogenicity of QLF31907
up to 2 years
overall survival(OS)
up to 2 years
maximum plasma concentration (Cmax) of QLF31907
up to 2 years
Study Arms (2)
QLF31907 in combination with Irinotecan
EXPERIMENTALQLF31907 in combination with Docetaxel
EXPERIMENTALInterventions
intravenous administration, once every 3 weeks
intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
intravenous administration, 75mg/m2, d1, every 3 weeks
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2024
First Posted
May 1, 2024
Study Start
June 15, 2024
Primary Completion
June 15, 2025
Study Completion (Estimated)
December 15, 2026
Last Updated
May 1, 2024
Record last verified: 2024-04