Clinical trials: Neoplasms, Oral
Advanced Solid Tumor (Phase 1)
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD)…
- Trial name
- NCT07163325
- Testing
- EP102
- Where
- 11 sites in Belgium, Czechia and 2 more
- Volunteers
- 48 people
- Sponsor
- Epics Therapeutics
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
Neoplasms
BIBW 2992 After Administration of Docetaxel in Patients With Advanced Solid Tumors
Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)
- Trial name
- NCT02171676
- Testing
- Docetaxel, BIBW 2992
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
Metastatic Pancreatic Cancer
A Study to Assess an ATX Inhibitor (IOA-289) in Patients With Metastatic Pancreatic Cancer
The objective of study IOA-289-102 is to evaluate the safety and tolerability of escalating doses of IOA-289 in patients with metastatic pancreatic cancer in combination with standard chemotherapy consisting of gemcitabine and…
- Trial name
- NCT05586516
- Testing
- IOA-289
- Where
- 3 sites in Italy, United Kingdom
- Volunteers
- 16 people
- Sponsor
- iOnctura
Prostate Neoplasms
A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate…
- Trial name
- NCT00600535
- Testing
- Stage 1 Group 1: abiraterone acetate, Stage 1 Group 2: abiraterone acetate, Stage 2: abiraterone acetate
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Cougar Biotechnology, Inc.
Oral Mucositis
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.
- Trial name
- NCT01385748
- Testing
- Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg
- Where
- 51 sites in United States, France and 4 more
- Volunteers
- 183 people
- Sponsor
- Valerio Therapeutics
Low Risk Myelodysplastic Syndromes
RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms
This study will evaluate orally administered RVU120, a novel small molecule Cyclin-dependent Kinase (CDK) 8/19 inhibitor, in terms of erythroid hematologic improvement (HI-E) and safety in participants with lower-risk…
- Trial name
- (MDS) (NCT06243458)
- Testing
- RVU120 (SEL120)
- Where
- 25 sites in France, Germany and 3 more
- Volunteers
- 41 people
- Sponsor
- GCP-Service International West GmbH
Glioblastoma Multiforme of Brain, Glioma
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic…
- Conditions
- Glioblastoma Multiforme of Brain, Glioma, Glioblastoma
- Trial name
- NCT07464925
- Testing
- GLIX1
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tetragon Biosciences Ltd
Relapsed Adult AML
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
- Trial name
- NCT06613217
- Testing
- zelenirstat
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Pacylex Pharmaceuticals
Solid Tumors With PTCH1 Loss-of-function Mutations
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF)…
- Trial name
- NCT05199584
- Testing
- ENV-101 (taladegib)
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Biomedicines, Inc.
Mucositis Oral
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency.
- Trial name
- NCT03577535
- Testing
- Oncoxin®
- Where
- Russia
- Volunteers
- 15 people
- Sponsor
- Catalysis SL
Advanced Solid Malignancies, Hematologic Malignancies
Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.
- Trial name
- NCT01351350
- Testing
- MLN0128, paclitaxel, trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Infertility, Female, Polycystic Ovary Syndrome
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertilization cycle in patients with…
- Trial name
- NCT04670393
- Testing
- FertyBiotic Woman Plus
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fertypharm
Solid Tumors, Adult
Study of ON 123300 in Patients With Advanced Cancer
This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials.
- Trial name
- NCT04739293
- Testing
- ON123300
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Traws Pharma, Inc.
Advanced Solid Tumors
Study of Intermittent OSI-906 Dosing
Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules.
- Trial name
- NCT00514306
- Testing
- OSI-906
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 79 people
- Sponsor
- Astellas Pharma Inc
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Superficial Esophageal Cancer
Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial Esophageal Cancer
The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial…
- Trial name
- NCT02866019
- Testing
- CLS2702C/CLS2702D
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- CellSeed Inc.
Neoplasms, Cancer
Safety of CHIR-258 (TKI258) in Advanced Solid Tumors
Phase I dose finding study in solid tumors.
- Conditions
- Neoplasms, Cancer, Tumors
- Trial name
- NCT01270906
- Testing
- CHIR-258 (TKI258)
- Where
- 2 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
- Trial name
- FORTIFI-HN01 (NCT06788990)
- Testing
- Ficerafusp alfa, Pembrolizumab (KEYTRUDA®)
- Where
- 231 sites in United States, Argentina and 26 more
- Volunteers
- 650 people
- Sponsor
- Bicara Therapeutics
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care…
- Trial name
- NCT07570979
- Testing
- INR731, Enzalutamide, Abiraterone
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
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