Clinical trials: Dose-escalation
Randomised Clinical Trial, Double Blind
Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study. Forty-two flavivirus-naïve adults will be enrolled and will receive 3 administrations of VLPDEN-02 or control at days 0, 28, and 56.
- Conditions
- Randomised Clinical Trial, Double Blind, Dengue, Challenge Test
- Trial name
- NCT07831473
- Testing
- VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- VLP Therapeutics
Maximum Tolerated Dose, Dose Escalation
Study to Evaluate the Safety and Tolerability of AD-NP1 in Healthy Human Adult Volunteers
This is a Phase 1 single-blind, placebo-controlled, dose-escalation study designed to evaluate the safety of AD-NP1, a humanized monoclonal antibody targeting human ectonucleotide pyrophosphatase/phosphodiesterase-1 (ENPP1).
- Trial name
- NCT07762001
- Testing
- AD-NP1
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Arjun Deb, MD
Prostate Cancer (Adenocarcinoma), Prostate Brachytherapy
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
PRO-BOOST-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane…
- Conditions
- Prostate Cancer (Adenocarcinoma), Prostate Brachytherapy, Stereotactic Body Radiation Therapy (SBRT), Dose Escalation: Solid Tumors
- Trial name
- PRO-BOOST-LC (NCT07426055)
- Testing
- Stereotactic Body Radiotherapy (SBRT) Monotherapy, External Beam Radiotherapy (EBRT) Backbone, High-Dose-Rate Brachytherapy Boost
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
Prostate Cancer, Brachytherapy
PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer
PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET/CT, without distant metastatic disease.
- Conditions
- Prostate Cancer, Brachytherapy, Stereotactic Body Radiation Therapy (SBRT), Dose Escalation: Solid Tumors
- Trial name
- PRO-BOOST-N (NCT07426094)
- Testing
- Ultrahypofractionated Whole-Pelvis Radiotherapy, SBRT-Based Prostate Radiotherapy (No Boost), Ablative Prostate Boost
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in, HNSCC for Phase 2 Dose Expansion
Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors
This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.
- Conditions
- Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in, HNSCC for Phase 2 Dose Expansion, NSCLC for Phase 2 Dose Expansion
- Trial name
- NCT03744468
- Testing
- Surzebiclimab, Tislelizumab, Alcestobart
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 147 people
- Sponsor
- BeiGene
Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma
Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
- Trial name
- NCT03739931
- Testing
- mRNA-2752, Durvalumab
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 134 people
- Sponsor
- ModernaTX, Inc.
Head and Neck Cancer, Hypoxia
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT.
- Conditions
- Head and Neck Cancer, Hypoxia, FMISO, Dose Escalation
- Trial name
- FARHEAD (NCT05348486)
- Testing
- Dose escalation
- Where
- 3 sites in Czechia
- Volunteers
- 120 people
- Sponsor
- University Hospital Olomouc
Dose Escalation and Safety
NXC-201 (formerly HBI0101) Multiple Myeloma
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
- Trial name
- NCT04720313
- Testing
- NXC-201 (formerly HBI0101)
- Where
- Israel
- Volunteers
- 160 people
- Sponsor
- Hadassah Medical Organization
Esophageal Cancer, Salvage Radiotherapy
Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018.
- Conditions
- Esophageal Cancer, Salvage Radiotherapy, Dose-escalation, Mediastinal Lymph Node Recurrence
- Trial name
- NCT03990532
- Testing
- treatment group(phase I), treatment group (phase II)
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Ruijin Hospital
Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma
Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma
This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD)…
- Trial name
- NCT04984434
- Testing
- F182112
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Prostate Cancer, Biochemical Recurrence
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a…
- Conditions
- Prostate Cancer, Biochemical Recurrence, Radiation, Hypofractionation
- Trial name
- SHARE (NCT03920033)
- Testing
- Salvage radiation therapy
- Where
- 2 sites in South Korea
- Volunteers
- 288 people
- Sponsor
- Asan Medical Center
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Stage III Non-small Cell Lung Cancer, Individualized Radiation Dose Escalation
Individualized Dose Prescription in Advanced Stage Lung Cancer Patients Using Modern (Chemo)Radiotherapy
The aim of this present study is to test the feasibility and toxicity of individualized hypofractionated radiotherapy, and to report outcome data.
- Trial name
- IDEAL-VMAT (NCT01577212)
- Testing
- Individualized dose escalation
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Radboud University Medical Center
Dose Escalation: Solid Tumors, MTD: Soft Tissue Sarcomas
A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas
Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin administered q 3 weeks in patients with advanced solid…
- Trial name
- NCT00878800
- Testing
- PXD101, Doxorubicin
- Where
- 3 sites in Denmark, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Valerio Therapeutics