Hoboken (antwerpen), Belgium
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
Phase
1Span
204 weeksSponsor
iTeos TherapeuticsWilrijk
Recruiting
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
In this study, patients with malignant epidural spinal cord compression (MESCC), Bilsky grade 1c, 2 and 3 who are ambulatory with or without aid (rollator, cane, one persons help) will be treated by separation surgery followed by SABR (5x 8.0 Gy postoperative) (control arm) or SABR alone (5x 8.0 Gy) (study arm). The primary objective of the study is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, ...); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention. For each participant, the study starts once written informed consent is provided and is composed by 4 study phases: a screening phase, randomisation, a treatment phase and a follow-up phase. The screening phase will allow for assessment of subject eligibility before randomisation and treatment. Demographic data, disease and spinal metastases characteristics and previous anticancer therapies will be recorded. Once all screening procedures are completed, eligibility will be determined according to the inclusion/exclusion criteria. Randomisation will be performed in a 1:1 ratio to the control arm (separation surgery followed by SABR) and the study arm (SABR) using an electronic randomisation tool in the eCRF. Treatment will be aimed to start as soon as possible, but certainly within 21 days after randomisation (surgery or upfront SABR). Surgical planning is done by the treating neurosurgeon in the participating center where the patient was included. Image-guided fractionated SABR using a SIB technique to the high-dose PTV will be delivered in 5 fractions of 8 Gy to a total of 40 Gy and to the conventional-dose PTV delivered simultaneously in 5 fractions of 4 Gy to a total of 20 Gy. At 6 weeks (+/-1 week) after the last RT session following information will be obtained (preferentially by digital consult): 1. Ambulatory status defined as: being able to walk 10m without aid, being able to walk 10m with aid (cane, rollator, one persons help, ...), not being able to walk 2. WHO performance status 3. Acute and late toxicity assessment: as measured with CTCAE version 5.0 4. Need for re-intervention, date and type of reintervention (surgery or radiotherapy), reason (wound infection, neurologic decline, loss of ability to walk or other) 5. Pain response: VAS pain score 6. Survival data (survival status, date of death, primary cause of death) At 3 and 6 months (+/-3 weeks) after the last RT session following information will be obtained by physical or digital consult: 1. Ambulatory status defined as: being able to walk 10m without aid, being able to walk 10m with aid (cane, rollator, one persons help, ...), not being able to walk 2. WHO performance status 3. Concomitant medications and systemic anticancer therapies 4. QoL according to the EORTC QLQ-C15 & BM22 questionnaires 5. Acute and late toxicity assessment: as measured with CTCAE version 5.0 7. Need for re-intervention, date and type of reintervention (surgery or radiotherapy), reason (wound infection, neurologic decline, loss of ability to walk or other) 6. Pain response: VAS pain score 7. Physical examination: body weight 8. Local control 9. Survival data (survival status, date of death, primary cause of death) At 12 and 24 months (+/-3 weeks) after the last RT session following information will be obtained (preferentially by digital consult): 1. Ambulatory status defined as: being able to walk 10m without aid, being able to walk 10m with aid (cane, rollator, one persons help, ...), not being able to walk 2. Need for re-intervention, type of reintervention 3. Survival data (survival status, date of death, primary cause of death) 4. Local control (only if information is available in medical record as per standard of care)
Phase
N/ASpan
260 weeksSponsor
Cancer Research AntwerpWilrijk
Recruiting
The RECLAIM Study.
Phase
N/ASpan
136 weeksSponsor
Salvia BioElectronicsWilrijk
Recruiting
ELVN-002 with Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
Parts 1 and 3 of this study are designed to evaluate preliminary safety, tolerability, and pharmacokinetics (PK) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. In addition, Part 3 will evaluate the preliminary efficacy of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive solid tumors. Part 2 of this study will evaluate the preliminary safety, tolerability, and PK of ELVN-002 in combination with trastuzumab and chemotherapy; capecitabine and oxaliplatin(CAPEOX) or 5-fluorouracil (5-FU), leucovorin (LCV) and oxaliplatin (mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer, or eribulin or capecitabine in participants with advanced-stage HER2-positive breast cancer, or paclitaxel in participants with advanced stage solid tumors. In part 4, the preliminary safety, tolerability, PK, and efficacy of ELVN-002 in combination with trastuzumab and CAPEOX or mFOLFOX6 will be evaluated in participants with HER2-positive colorectal cancer.
Phase
1Span
218 weeksSponsor
Enliven TherapeuticsWilrijk
Recruiting
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Phase
1Span
179 weeksSponsor
OnKure, Inc.Wilrijk
Recruiting
A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically
Phase
1/2Span
161 weeksSponsor
iOmx Therapeutics AGWilrijk
Recruiting
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
This study will combine MR imaging techniques together with elaborate neuropsychological assessments and RT dosimetry in 120 patients who will be examined baseline (before RT) and followed longitudinally after RT. The first objective is to build an NTCP model for neurocognitive decline after RT (for each cognitive domain separately), linking dose-volume parameters to structures within the brain susceptible to neurological damage and neurocognitive decline after radiotherapy. These NTCP models can be used to make predictions on neurocognitive decline in future primary brain tumour patients receiving cranial RT. The second objective is to evaluate dose-dependent neurocognitive decline. In particular, the investigators will assess: - Prevalence and severity of neurocognitive decline after RT for all cognitive domains - Brain structures or functional brain connections important in neurocognitive functioning (based on dedicated MRI). - Dose-dependencies of specific neurocognitive skills after RT in adult brain tumour patients - Correlations between RT dosimetry and early brain changes (MRI)
Phase
N/ASpan
208 weeksSponsor
Universitaire Ziekenhuizen KU LeuvenWilrijk
Recruiting
Wilrijk
Recruiting
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
Phase
1/2Span
119 weeksSponsor
GlaxoSmithKlineWilrijk
Recruiting
Healthy Volunteers
Differential Target Multiplexed Spinal Cord Stimulation
Phase
N/ASpan
256 weeksSponsor
Moens MaartenWilrijk
Recruiting