Clinical trials: NEC, open to volunteers
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
- Trial name
- NCT06701396
- Testing
- Tasimelteon
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Vanda Pharmaceuticals
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310.
- Conditions
- Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology, Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology
- Trial name
- NCT07707895
- Testing
- Obrixtamig, ZL-1310, Atezolizumab
- Where
- 27 sites in United States, Australia and 9 more
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
Large Cell Neuroendocrine Carcinoma, Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC)
Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [212Pb]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3…
- Conditions
- Large Cell Neuroendocrine Carcinoma, Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC), Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), Small Cell Lung Cancer (SCLC)
- Trial name
- NCT07278479
- Testing
- [212Pb]Pb-MP0712, [203Pb]Pb-MP0712
- Where
- 8 sites in United States
- Volunteers
- 138 people
- Sponsor
- Molecular Partners AG
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.
Small Cell Lung Cancer (SCLC ), Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
A First-in-human (FIH), Phase 1 Study of ML261, an Autologous Potency Enhanced Anti-DLL3 CAR T Cell Therapy, in Participants With R/R SCLC or Select NECs (SPECTRAL-1)
This is a first-in-human (FIH), open-label, Phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of ML261, an autologous potency enhanced anti-DLL3 CAR T cell therapy, in participants…
- Conditions
- Small Cell Lung Cancer (SCLC ), Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), Gastroenteropancreatic NEC (GEP NEC), Neuroendocrine Prostate Cancer (NEPC)
- Trial name
- NCT07488923
- Testing
- ML261
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- Moonlight Bio, Inc
Advanced Extrapulmonary Neuroendocrine Carcinoma
A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC
This trial is a randomized, double-blind, placebo-controlled multicenter phase III clinical study aiming to evaluate the efficacy and safety of LBL-024 compared with placebo in combination with etoposide and cisplatin or…
- Trial name
- NCT07720193
- Testing
- LBL-024 for Injection, Etoposide injection, Cisplatin injection
- Where
- 36 sites in China
- Volunteers
- 280 people
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
Locally Advanced or Metastatic Urothelial Carcinoma
A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma
The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
- Trial name
- NCT07393542
- Testing
- SHR-A2102 and Adebrelimab, Gemcitabine and cisplatin / carboplatin
- Where
- China
- Volunteers
- 453 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging properties of [111In]In-ETN029 in patients aged ≥ 18 years with locally advanced…
- Conditions
- Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung, Neuroendocrine Prostate Cancer, Gastroenteropancreatic Neuroendocrine Carcinoma
- Trial name
- NCT07006727
- Testing
- 225Ac-ETN029, 111In-ETN029
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 116 people
- Sponsor
- Novartis Pharmaceuticals
Recurrent or Metastatic Solid Tumors
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma…
- Trial name
- NCT06330064
- Testing
- Ifinatamab deruxtecan
- Where
- 120 sites in United States, Argentina and 16 more
- Volunteers
- 680 people
- Sponsor
- Daiichi Sankyo
Small-cell Lung Cancer, Neuroendocrine Carcinomas
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
- Conditions
- Small-cell Lung Cancer, Neuroendocrine Carcinomas, Solid Tumor Show to Express DLL3
- Trial name
- NCT07174583
- Testing
- IDE849, durvalumab, IDE161
- Where
- 13 sites in United States
- Volunteers
- 262 people
- Sponsor
- IDEAYA Biosciences
Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC)
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer, Gastric Cancer
- Trial name
- NCT06943521
- Testing
- MT-4561
- Where
- 6 sites in United States, Japan
- Volunteers
- 27 people
- Sponsor
- Tanabe Pharma America, Inc.
Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Cancer (LCNEC)
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig…
- Conditions
- Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Cancer (LCNEC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
- Trial name
- NCT05652686
- Testing
- Peluntamig (PT217), Carboplatin + Etoposide, Paclitaxel.
- Where
- 15 sites in United States
- Volunteers
- 203 people
- Sponsor
- Phanes Therapeutics
Advanced Neuroendocrine Carcinoma
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
- Trial name
- NCT06157827
- Testing
- LBL-024 for Injection, Etoposide Injection, Carboplatin Injection
- Where
- 25 sites in China
- Volunteers
- 178 people
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
SCLC, NEC
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
- Trial name
- NCT07416695
- Testing
- HLX3901
- Where
- 2 sites in China
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Necrotizing Enterocolitis
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or…
- Trial name
- NEC (NCT06315738)
- Testing
- ST266
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Noveome Biotherapeutics, formerly Stemnion
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Neuroendocrine Carcinomas (NEC)
ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants…
- Trial name
- NCT07833839
- Testing
- ZG005 for Injection, Etoposide Injection, Cisplatin Injection
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Small Cell Lung Cancer, Neuroendocrine Carcinoma
ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
- Trial name
- NCT07038096
- Testing
- ZG006, ZG005
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd