Clinical trials: Phase 1b
Ewing Sarcoma
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric…
- Trial name
- NCT07297979
- Testing
- Xaluritamig
- Where
- 13 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
The purpose of this study is to determine the safety, pharmacokinetic (PK), and tolerability of multiple treatment cycles of oral mirdametinib in infants and toddlers (0 to less than [<] 24 months of age) with measurable…
- Trial name
- NCT07850635
- Testing
- Mirdametinib
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor
Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors
iSTAR is an open-label, multi-center, phase 1b study of oral XPO1 inhibitor selinexor and oral MDM2 inhibitor idasanutlin in children with progressive or recurrent atypical teratoid/rhabdoid tumors (AT/RT), malignant rhabdoid…
- Conditions
- Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor of CNS, CNS Tumor
- Trial name
- NCT05952687
- Testing
- Idasanutlin, Selinexor
- Sponsor
- St. Jude Children's Research Hospital
IDH1-mutant Glioma, IDH2-mutant Glioma
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib.
- Trial name
- NCT06478212
- Testing
- Vorasidenib, Temozolomide (TMZ)
- Where
- 28 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- Institut de Recherches Internationales Servier
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
Cancer, Solid Tumor
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
- Trial name
- NCT05741242
- Testing
- Personalized Synthetic Long Peptide Vaccine
- Where
- 6 sites in United States
- Volunteers
- 136 people
- Sponsor
- Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Colorectal Cancer, Locally Advanced
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.
- Conditions
- Colorectal Cancer, Locally Advanced, Metastatic Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT00819169
- Testing
- AMG 479, AMG 655
- Volunteers
- 89 people
- Sponsor
- NantCell, Inc.
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy…
- Trial name
- ABCI (NCT05802264)
- Testing
- ABCI
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Cystetic Medicines, Inc.
Classical Hodgkin Lymphoma, Hodgkin Disease Refractory
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy
This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients…
- Conditions
- Classical Hodgkin Lymphoma, Hodgkin Disease Refractory, Hodgkin Disease Recurrent
- Trial name
- ACTION (NCT05352828)
- Testing
- Nivolumab, Autologous CD30.CAR-T, Fludarabine
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Tessa Therapeutics
Relapsed Ewing Sarcoma
A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further…
- Trial name
- NCT03514407
- Testing
- INCB059872
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 25 people
- Sponsor
- Incyte Corporation
Dexmedetomidine, Mechanical Ventilation Complication
DOSE Trial of Opioid Sparing Effect
Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children.
- Conditions
- Dexmedetomidine, Mechanical Ventilation Complication, Critically Ill
- Trial name
- DOSE (NCT03938857)
- Testing
- Fentanyl, Dexmedetomidine
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Type 1 Interferonopathies
Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies
Open-Label Study (Phase Ib) of Type 1 Interferonopathy patients receiving IMSB301 monotherapy.
- Trial name
- NCT07364513
- Testing
- IMSB301
- Where
- Australia
- Volunteers
- 6 people
- Sponsor
- ImmuneSensor Therapeutics Inc.
Progressive Pediatric Brain Cancer
Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer
This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in…
- Trial name
- NCT07732413
- Testing
- NLG802 (indoximod Prodrug), Temozolomide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Lumos Pharma
Hepatitis C, Chronic
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
- Trial name
- NCT01425190
- Testing
- Boceprevir
- Volunteers
- 16 people
- Sponsor
- Merck Sharp & Dohme LLC
Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia
Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab and how well the combination works…
- Trial name
- NCT07133997
- Testing
- Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Blinatumomab
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- City of Hope Medical Center
Non Small Cell Lung Carcinoma, Renal Cell Carcinoma
Retifanlimab and Ruxolitinib In Solid Malignancies
The goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma.
- Trial name
- PRISM (NCT07219576)
- Testing
- Ruxolitinib, Retifanlimab
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma…
- Trial name
- NCT02518113
- Testing
- LY3039478, Dexamethasone
- Where
- 22 sites in United States, France and 3 more
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Idiopathic Short Stature
A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and…
- Trial name
- NCT07450053
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.