CLINICAL TRIALS UNIT

The most important feature of the Koç University Hospital Clinical Trials Unit (CTU) is that it provides volunteers with quality healthcare services and improves their access to new treatment methods and drugs in a safe environment. Our research and development efforts, particularly focused on combating cancer, not only contribute to science but also offer hope to patients. Innovative drug and medical device research, some of which are first-in-human, provides our volunteers valuable access to new treatments. Our Unit provides a workspace for physician-scientists and nurses in the field of clinical research. With its “Phase 1 Clinical Research Center,” the CTU is one of the few exemplary clinical research centers in Türkiye and neighboring countries. In our center, Phase 1-2-3 drug studies and medical device studies are conducted.
 

The Unit has 7 patient beds in the Phase 1 Center, 4 outpatient examination rooms and its own pharmacy and laboratory. The Unit currently runs 30+ clinical trials in partnership with global pharmaceutical and medical device companies as well as distinguished academic centers including Oxford University and Mayo Clinic.

Thanks to our strategic collaborations with BioNTech and other partners, as well as the quality healthcare services of Koç University Hospital, we bring innovative medical technologies such as mRNA-based cancer vaccines, immunotherapies, and cell therapies to patients in Türkiye.
 

Our Unit is fully licensed by the Turkish Medicines and Medical Devices Agency and partners with Mayo Clinic to improve the quality of clinical trials.

To learn more about our ongoing studies, you can review the list on this page and contact our respective physician. For inquiries, please contact us at ctu@kuh.ku.edu.tr or call Koç University Hospital Call Center: +90 (850) 250 82 50

 

Ongoing Projects

Sponsor Protocol Code Trial Name Principal Investigator Phase
Taewoong Medical Co. TWTPV-E1001 PULSTA™ Transcatheter Pulmonary Valve (TPV)
Pre-approval Study
ENDER ÖDEMİŞ (Prof.Dr.) Medical Device
AstraZeneca Mono-Ola1- A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Advanced (FIGO Stage III-IV) High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1) FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 3
Lilly I8F-MC-GPGN The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) OĞUZHAN DEYNELİ (Prof.Dr.) Phase 2b
ROCHE GO42909 Phase III Randomized, Open-Label,Multicenter Study Evaluating Efficacy And Safety Of Mosunetuzumab In Combination With Lenalidomide In Comparison To Rituximab In Combination With Lenalidomide In Patients With Follicular Lymphoma After At Least One Line Of Systemic Therapy MELTEM AKAY (Prof.Dr.) Phase 3
RS Research RS-0139 A multicenter, open-label, two-step, phase Ia/Ib study of tumor-targeted prodrug RS 0139 in patients with recurrent, locally advanced and/or metastatic solid tumors HAKAN ORER (Prof.Dr.) Phase 1a/1b
AbbVie M20-429 A Single Arm, Open-Label, Phase lb Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms MEHMET FATİH ERBEY (Prof.Dr.) Phase 1b
Novartis CKJX839D12302 A randomized, double blind, placebo conrolled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients DİLEK URAL (Prof.Dr.) Phase 3
AstraZeneca D926FC00001 A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab
Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)
PERRAN FULDEN YUMUK (Prof.Dr.) Phase 1b
GSK 219288 Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2) SÜLEYMAN CİHAN YURTAYDIN (Prof.Dr.) Phase 3
Boehringer Ingelheim 1404-0040 A Phase 3, randomised, double-blind, parallel-group, event driven, cardiovascular safety study with BI 456906 administered
subcutaneously compared with placebo in participants with
overweight or obesity with established cardiovascular disease
(CVD) or chronic kidney disease, and/or at least two weight related complications or risk factors for CVD
DİLEK YAZICI (Prof.Dr.) Phase 3
Johnson and Johnson 88998377LYM1001 A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants with Relapsed/Refractory B-cell NHL SİNEM CİVRİZ BOZDAĞ ( Prof.Dr.) Phase 1
Syneos Health IMVT-1401-3202 A Phase 3, Multi-center, Randomized,
Quadruple-masked, Placebo-controlled Study of Batoclimab for
the Treatment of Participants with Active Thyroid Eye Disease
(TED)
OĞUZHAN DEYNELİ (Prof.Dr.) Phase 3
Sanofi EFC17504 A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis. AYŞE ALTINTAŞ (Prof.Dr.) Phase 3
Regeneron Pharmaceuticals, Inc. R3767-ONC-2235 A Randomized, double blind Phase 2/3 study of Fianlimab (Anti-Lag-3 Antibody) in combination with Cemiplimab (Anti-PD-1 Antibody) versus Cemiplimab monotherapy in first-line treatment of patients with advanced non small cell lung cancer(NSCLC) WİTH TUMORS EXPRESSİNG PD-L1 ≥50% ŞAHİN LAÇİN (Doç.Dr.) Phase 3
Johnson and Johnson 56021927PCR3015 Randomized, Controlled, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET, with an Observational Cohort DENİZ TURAL (Prof.Dr.) Phase 2

inTUMO Therapeutics, Inc.
INTUMO-002 A study to evaluate the safety and performance of Ionic Liquid on liver tumors in patients requiring tumor ablation
A prospective, single-arm, single-center clinical trial
FATİH SELÇUKBİRİCİK (Prof.Dr.) Medical Device
AstraZeneca D9185C00001 A Phase III, Multicentre, Randomised, Double-blind, Parallel-group,
Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)
ÖNDER ERGÖNÜL (Prof.Dr.) Phase 3
BioNTech SE BNT116-01 LuCa-MERIT-1: First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 1
GSK GSK4057190A A randomized, double-blind, placebo-controlled phase 3 study to evaluate dostarlimab as sequential therapy after chemoradiation in participants with locally advanced unresected head and neck squamous cell carcinoma. ŞAHİN LAÇİN (Doç.Dr.) Phase3
BioNTech SE BNT327-01 A Phase II, multi-site, open-label, parallel group trial of BNT327 in combination with chemotherapy for participants with untreated extensive-stage small-cell lung cancer and participants with previously treated small-cell lung cancer FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 2
BioNTech SE BNT327-02 A Phase II, multi-site, randomized, open-label clinical trial to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapeutic agents as first- and second-line treatment in triple-negative breast cancer FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 2
Amgen AMGEN 20230298 A phase 1b study evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of subcutaneous tarlatamab in subjects with extensive stage small cell lung cancer (DeLLphi-308). PERRAN FULDEN YUMUK (Prof.Dr.) Phase 1b
Cynata Therapeutics Limited CYP-GvHD-P2-01_HAB91733 A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to
Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
SİNEM CİVRİZ BOZDAĞ ( Prof.Dr.) Phase 2

inTUMO Therapeutics, Inc.
INTUMO-003 Evaluation of the Safety and Efficacy of Ionic Liquid in the Treatment of Symptoms in Patients with Benign Prostatic Hyperplasia YAKUP KORDAN (Prof.Dr.) Medical Device
GSK 222291 A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Alcohol-related Liver Disease (ALD) -STARLIGHT SÜLEYMAN CİHAN YURTAYDIN (Prof.Dr.) Phase 2b
89BIO Inc. BIO89-100-132 A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) MÜJDAT ZEYBEL (Prof.Dr.) Phase 3
OncoC4 Inc. PRESERVE-003 Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors. FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 3
Merck Sharp & Dohme LLC V940-005 Phase 2, randomized, double-blind, placebo- and active-comparator-controlled clinical study of adjuvant V940 (mRNA-4157) plus pembrolizumab versus adjuvant placebo plus pembrolizumab in participants with high-risk muscle-invasive urothelial carcinoma post-radical resection. DENİZ TURAL (Prof.Dr.) Phase 2
Merck Sharp & Dohme LLC MK-5684-004 A phase 3, randomized, open-label study of MK-5684 versus alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) that progressed on or after prior treatment with one next-generation hormonal agent (NHA). DENİZ TURAL (Prof.Dr.) Phase 3
Astellas Pharma Global Development Inc. 1517-CL-1003 A phase 3, open-label, uncontrolled study to evaluate the activity, safety, pharmacokinetics and pharmacodynamics of roxadustat for the treatment of anemia in pediatric participants with chronic kidney disease. İLMAY BİLGE (Prof.Dr.) Phase 3
GSK 223559 A phase I/II study of GSK5733584 in combination with anti-cancer therapies for advanced solid tumors. FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 1
Regeneron Pharmaceuticals, Inc. R3767-ONC-2266 A phase 2 peri-operative trial of fianlimab and cemiplimab in combination with chemotherapy versus cemiplimab in combination with chemotherapy in patients with resectable early stage (stage ii to iiib [n2]) nsclc ŞAHİN LAÇİN (Doç.Dr.) Phase 2
Pfizer Inc. C2321003 A Phase 3, Randomized, Double Blind, Placebo Controlled Study of PF-06821497 (Mevrometostat) With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (MEVPRO-2) DENİZ TURAL (Prof.Dr.) Phase 3
BioNTech SE BNT327-03 A Phase III, multisite, double-blinded randomized trial of BNT327 in combination
with chemotherapy (etoposide/carboplatin) compared to atezolizumab in
combination with chemotherapy (etoposide/carboplatin) in participants with first line extensive-stage small-cell lung cance
FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 3
BioNTech SE BNT327-06 A Phase II/III, multisite, randomized master protocol for a global trial of BNT327 in combination with chemotherapy and other investigational agents in first-line non-small cell lung cancer FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 2/3
Pfizer Inc. C2321014 A phase 3, randomized, open-label study of pf-06821497 (mevrometostat) in combination with enzalutamide compared with enzalutamide or docetaxel in participants with metastatic castration resistant prostate cancer previously treated with abiraterone acetate (MEVPRO-1) DENİZ TURAL (Prof.Dr.) Phase 3
Amgen 20210031 A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared with OPDIVO® (Nivolumab) in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma ŞEYDA GÜNDÜZ (Prof.Dr.) Phase 3
GSK 2857914 A Phase 1/2 open-label, multicentre, dose escalation and expansion study to investigate the safety, tolerability, and clinical activity of belantamab as monotherapy and in combination with other treatments in participants with multiple myeloma. SİNEM CİVRİZ BOZDAĞ ( Prof.Dr.) Phase 1/2
GSK 206867 A Phase 3, 24-week, randomized, double-blind, parallel-group Bayesian Dynamic Borrowing study comparing the efficacy, safety, tolerability and pharmacokinetics of FF/UMEC/VI with FF/VI in 12-17-year-old participants with inadequately controlled asthma on stable maintenance therapy with ICS/LABA CANSIN SAÇKESEN (Prof.Dr.) Phase 3
Merck Sharp & Dohme LLC MK-3120-002 A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of
MK-3120 in Participants with Advanced Solid Tumors
FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 1
Johnson and Johnson 75276617AML3001 A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy MELTEM AKAY (Prof.Dr.) Phase 3
Roche DC000129 Clinical study to evaluate the impact of the Accu-Chek SmartGuide CGM solution on the mean change in time in range of 70 - 180 mg/dl compared to SMBG OĞUZHAN DEYNELİ (Prof.Dr.) Medical Device
89BIO Inc. BIO89-100-131 A Phase 3 Study to Evaluate the Efficacy and Safety of
Pegozafermin in Subjects with Metabolic Dysfunction-Associated
Steatohepatitis (MASH) and Fibrosis
MÜJDAT ZEYBEL (Prof.Dr.) Phase 3
Boehringer Ingelheim 1404-0044 A randomised, double-blind, placebo-controlled, multicentre,
Phase III trial evaluating long-term efficacy and safety of
survodutide weekly injections in adult participants with non cirrhotic non-alcoholic steatohepatitis/metabolic associated
steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver
fibrosis
GENCO GENÇDAL (Doç.Dr.) Phase 3
Boehringer Ingelheim 1404-0064 A Phase III double-blind, randomised, placebo-controlled trial to
evaluate liver-related clinical outcomes and safety of once weekly
injected survodutide in participants with compensated non alcoholic steatohepatitis/metabolic dysfunction associated
steatohepatitis (NASH/MASH) cirrhosis
GENCO GENÇDAL (Doç.Dr.) Phase 3
GSK 223674 Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC) ŞEYDA GÜNDÜZ (Prof.Dr.) Phase 3
AstraZeneca D702AC00001 A Randomized, Phase III Study of Rilvegostomig in Combination
with Fluoropyrimidine and Trastuzumab Deruxtecan versus
Trastuzumab, Chemotherapy, and Pembrolizumab for the
First-line Treatment of HER2-positive Gastric Cancer
(ARTEMIDE-Gastric01)
FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 3
Bluejay Therapeutics, Inc. BJT-778-301 A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1) SÜLEYMAN CİHAN YURTAYDIN (Prof.Dr.) Phase 2b/3
BioNTech SE BNT327-07 A Phase II, multisite, open-label, single arm trial of BNT327 in combination with docetaxel in second-line stage IV non-small cell lung cancer (NSCLC) following chemoimmunotherapy FATİH SELÇUKBİRİCİK (Prof.Dr.) Phase 2