Clinical trials: open to volunteers, sponsored by Qilu Pharmaceutical Co., Ltd.
Extensive-stage Small Cell Lung Cancer
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in…
- Trial name
- NCT07802821
- Testing
- QLC5508, QL2107, Tislelizumab
- Where
- China
- Volunteers
- 556 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Extrapulmonary Neuroendocrine Carcinoma
QLC5508 vs. Investigator's Choice Chemotherapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 versus investigator's choice chemotherapy in participants with advanced EP-NEC that has failed after at least one…
- Trial name
- NCT07894211
- Testing
- Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen), QLC5508
- Volunteers
- 270 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metabolic Dysfunction-associated Steatohepatitis (MASH)
To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver…
- Trial name
- NCT07620366
- Testing
- QL2401 25 mg, QL2401 50 mg, QL2401 100 mg
- Volunteers
- 132 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Gastric or Gastroesophageal Junction Adenocarcinoma
QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ
This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of…
- Trial name
- NCT07716449
- Testing
- QLS31905, Sintilimab, Oxaliplatin
- Where
- China
- Volunteers
- 560 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
Comparative Study of QL1209 and Perjeta® in Healthy Male Participants
The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male…
- Trial name
- NCT07861139
- Testing
- QL1209, US-Perjeta®
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Cancer Cachexia, Cancer Cachexia Syndrome
The First in Human Study of QLS2319 in Healthy Subjects and Cancer Cachexia
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
- Trial name
- NCT07735104
- Testing
- QLS2319
- Where
- 2 sites in China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
RAS Wild-type Metastatic Colorectal Cancer
Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer.
- Trial name
- NCT07829588
- Testing
- QL1203 + mFOLFOX6, Vectibix®+ mFOLFOX6
- Volunteers
- 136 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Refractory or Relapsed Solid Tumors
Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction
A clinical trial of QLC5508 for advanced solid tumors The goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors.
- Trial name
- NCT07620041
- Testing
- QLC5508 (Investigational Product / Formulation T), QLC5508 (Reference Product / Formulation R), Itraconazole
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Cancer Treatment-Induced Thrombocytopenia
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.
- Trial name
- NCT06456528
- Testing
- QL0911
- Where
- 2 sites in China
- Volunteers
- 235 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants…
- Trial name
- NCT07751315
- Testing
- Ia:QLS2404 very low dose, Ia:QLS2404 low dose, Ia:QLS2404 middle dose
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues.
- Conditions
- IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G), Primary Membranous Nephropathy
- Trial name
- NCT07730632
- Testing
- QLS7305 Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN)
Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA.
- Conditions
- Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN), Neutropenia
- Trial name
- NCT07724756
- Testing
- Albipagrastim alf
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Prostate Cancer
QLF4113 in Participants With Metastatic Prostate Cancer
This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in…
- Trial name
- NCT07636707
- Testing
- QLF4113 for injection
- Volunteers
- 140 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Prostate Cancer
QLC5508 in Participants With Metastatic Prostate Cancer
This is a randomized, open-label, active-controlled, multicenter Phase III trial evaluating QLC5508 versus docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior…
- Trial name
- NCT07632690
- Testing
- QLC5508, Docetaxel
- Volunteers
- 700 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Relapsed or Refractory Multiple Myeloma
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and…
- Trial name
- NCT07018050
- Testing
- QLS32015, Pomalidomide, Dexamethasone
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced Prostate Cancer
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or…
- Trial name
- NCT07198633
- Testing
- QLC5508, abiraterone acetate, enzalutamide
- Where
- China
- Volunteers
- 212 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Relapsed or Refractory Multiple Myeloma
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd/Sd for the treatment of relapsed or refractory multiple myeloma.
- Trial name
- NCT07138209
- Testing
- QLS32015, Pomalidomide, Selinexor
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced ER+/HER2- Breast Cancer
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast…
- Trial name
- NCT07235176
- Testing
- QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypertension (HTN)
QLS1410 in Participants With Uncontrolled Hypertension
The goal of this clinical trial is to measure the efficacy and safety of QLS1410 in participants with uncontrolled hypertension (uHTN) or treatment-resistant hypertension (rHTN).
- Trial name
- NCT07489612
- Testing
- Dose 1 of QLS1410, Dose 2 of QLS1410, Dose 3 of QLS1410
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Solid Tumor Cancer
QLS5212 for Participants With Advanced Solid Tumors
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally…
- Trial name
- NCT07467629
- Testing
- QLS5212
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.