Pembrolizumab, Ifx-Hu2.0
Advanced Or Metastatic Merkel Cell Carcinoma
Phase II/III
Recruiting
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Apr 14, 2025
―
Pembrolizumab, Ifx-Hu2.0
Advanced Or Metastatic Merkel Cell Carcinoma
Phase I
Recruiting
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
Apr 03, 2025
―
Rem-001 Photodynamic Therapy
Cutaneous Breast Cancer
Phase II
Active Not Recruiting
Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)
May 09, 2022
―
Val-083, Dianhydrogalactitol, Physician's Choice Of Salvage Therapy - Temozolomide, Physician's Choice Of Salvage Therapy - Lomustine, Physician's Choice Of Salvage Therapy - Carboplatin
Glioma, Glioblastoma, Glioblastoma Multiforme, Gbm, Brain Cancer
Phase III
Terminated
VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
May 03, 2017
―
Val-083 (Dianhydrogalactitol)
Glioma, Glioblastoma, Glioblastoma Multiforme, Gbm, Brain Cancer
Phase II
Completed
Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression
Jan 27, 2017
―
Val-083, Dianhydrogalactitol
Glioma, Glioblastoma, Glioblastoma Multiforme, Gbm, Brain Cancer
Phase II
Completed
Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting
Mar 16, 2016
―
Val-083 (Dianhydrogalactitol)
Glioma, Glioblastoma, Glioblastoma Multiforme, Gbm, Brain Cancer
Phase I/II
Completed
Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma
Nov 14, 2011
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does TuHURA Biosciences (PL3) have in its pipeline
PL3 is currently developing the following drugs: Pembrolizumab, Ifx-Hu2.0, Pembrolizumab, Ifx-Hu2.0, Rem-001 Photodynamic Therapy. These drug candidates are in various stages of clinical development as the company works toward FDA approval.