Clinical trials: sponsored by 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.
Carcinoma, Non-Small-Cell Lung
Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
- Trial name
- NCT07162883
- Testing
- QL2107, Keytruda®
- Where
- 84 sites in Bosnia and Herzegovina, China and 11 more
- Volunteers
- 146 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.
Plaque Psoriasis
A Phase 3 Clinical Study of QL2106 Injection
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis.
- Trial name
- NCT07511647
- Testing
- QL2106 injection, Tremfya®
- Where
- China
- Volunteers
- 318 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Schizophrenia
Study on the Efficacy and Safety of QLM1016 in Schizophrenia
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
- Trial name
- NCT06799559
- Testing
- 3-6mg QLM1016, 10-20 mg Aripiprazole oral solution film
- Where
- China
- Volunteers
- 402 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.
Prostate Cancer
Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.
- Trial name
- NCT06837896
- Testing
- QLG1080
- Where
- China
- Volunteers
- 111 people
- Sponsor
- 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
- Volunteers
- 556 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metabolic Dysfunction-Associated Steatohepatitis(MASH)
Safety, Tolerability, PK, PD, and Immunogenicity of QL2401 in Healthy Chinese Adults
This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple…
- Trial name
- NCT07331545
- Testing
- QL2401
- Where
- China
- Volunteers
- 71 people, healthy volunteers welcome
- 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.
Healthy Participants
A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
- Trial name
- NCT07479576
- Testing
- QL2106, Tremfye®
- Where
- China
- Volunteers
- 190 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.