Advanced Malignant Neoplasm Clinical Trial
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
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 15, 2026 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Qilu Pharmaceutical Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | phase Ib: Dose-limiting toxicity(DLT) | The DLT of QLF31907 combination therapy will be determined | 28 days | |
Primary | phase2: objective response rate(ORR) | the ORR of QLF31907 combinaton therapy will be determined | up to 2 years | |
Secondary | adverse events (AEs) of QLF31907 combination therapy | to evaluate the severity, incidence and causality of adverse events (AEs) | up to 2 years | |
Secondary | area under the concentration-time curve (AUC) of QLF31907 | the area under the concentration-time curve (AUC) of QLF31907 will be determined | up to 2 years | |
Secondary | Immunogenicity of QLF31907 | the anti-drug antibody(ADA) against QLF31907 will be determined | up to 2 years | |
Secondary | overall survival(OS) | the OS of QLF31907 combination therapy will be determined | up to 2 years | |
Secondary | maximum plasma concentration (Cmax) of QLF31907 | the maximum plasma concentration (Cmax) of QLF31907 will be determined | up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03671226 -
Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center
|
N/A | |
Recruiting |
NCT05048160 -
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03287492 -
RCT of QPS vs General Information Sheet
|
N/A | |
Recruiting |
NCT01549067 -
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey
|
N/A | |
Recruiting |
NCT04119037 -
Cordotomy in Reducing Pain in Patients With Advanced Cancer
|
N/A | |
Recruiting |
NCT04067336 -
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Recruiting |
NCT04585750 -
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
|
Phase 1/Phase 2 | |
Completed |
NCT02823652 -
Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
|
N/A | |
Completed |
NCT00244972 -
Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT06297642 -
TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT01582191 -
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03856060 -
Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits
|
N/A | |
Completed |
NCT04186884 -
Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
|
||
Completed |
NCT02583269 -
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Withdrawn |
NCT03868423 -
Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
|
Phase 2 | |
Terminated |
NCT02940223 -
Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
Active, not recruiting |
NCT03021486 -
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT03203525 -
Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer
|
Phase 1 | |
Completed |
NCT01624766 -
Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers
|
Phase 1 |