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Trial Title:
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
NCT ID:
NCT06394713
Condition:
Advanced Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Docetaxel
Irinotecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLF31907
Description:
intravenous administration, once every 3 weeks
Arm group label:
QLF31907 in combination with Docetaxel
Arm group label:
QLF31907 in combination with Irinotecan
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
Arm group label:
QLF31907 in combination with Irinotecan
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
intravenous administration, 75mg/m2, d1, every 3 weeks
Arm group label:
QLF31907 in combination with Docetaxel
Summary:
This study is designed to evaluate the safety and efficacy of QLF31907 combination
therapy in advanced malignant tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. subjects voluntarily participated and signed a written informed consent form;
2. age ≥18 years, male or female;
3. ECOG PS 0-1;
4. histopathologically diagnosed advanced malignant tumors;
5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014)
criteria;
6. adequate organ function;
Exclusion Criteria:
1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
2. received anti-tumor therapy within 4 weeks prior to the first study treatment;
3. history of autoimmune disease;
4. history of other active malignancies within 3 years prior to the first treatment;
5. history of serous cardiovascular events;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 15, 2024
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394713
