PhI/Ib FirstInHuman Investig SafeTolerabPharmBiologic&ClinicalActiv DF6215 Pa w/Adv Solid Tu
Jennifer Brooke Valerin
A Study On:
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposi's Sarcoma
Kidney
Larynx
Lip, Oral Cavity and Pharynx
Liver
Lung
Melanoma, Skin
Mycosis Fungoides
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder
Status:
Open
Eligibility
Male or female patients aged 18 years and over
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months
Adequate cardiac function
Normal pulmonary function
Adequate renal function
Effective contraception
A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors
Details
This study consists of a Dose Escalation part with 3+3 Dose Escalation and Safety/PK/PD subparts, and a Phase 1b Efficacy Expansion part that will explore the clinical activity and expand the understanding of its safety profile in patients with advanced (unresectable, recurrent, or metastatic) melanoma patients who have received immune checkpoint inhibitor therapy and progressed.
The United States Food and Drug Administration (US FDA) has recently recognized that, should certain conditions be met, such a design could expedite the development of a drug aimed to treat cancer. (US FDA, March 2022).
The primary objectives of the current study are consistent with those typical of Phase 1/1b oncology studies, including characterizing the safety and tolerability of an Investigational Medicinal Product (IMP), establishing an MTD, and determining a recommended range of doses for evaluation in future clinical studies, based on PK and pharmacodynamic effects (Ahn 1998, Gatsonis 1992, Dillman 1992, ICH E8).
The Sponsor and Investigators will perform this study in compliance with the protocol, Good Clinical Practice (GCP), and International Council for Harmonization (ICH) guidelines, and applicable regulatory requirements.
Eligibility
You can join if...
Adequate cardiac function defined by the absence of the following:
a) A clinically relevant abnormality on the electrocardiogram (ECG)
b) Clinically relevant coronary artery disease or uncontrolled congestive heart failure
c) Medically uncontrolled angina pectoris
d) An implantable pacemaker or automatic implantable cardioverter-defibrillator
e) A history of risk factors for ventricular tachycardia, torsades de pointes, fainting, unexplained loss of consciousness, or convulsions
f) A history of heart failure, congestive heart failure, myocardial infarction, cardiomyopathy, uncontrolled hypokalemia, hypomagnesemia, or hypoglycemia; any evidence of conduction abnormality (eg, increased QRS complex)
g) Congenital long QT syndrome or a prolonged QTc interval mean on screening ECG
h) QTc more than 470 msec
i) History of myocardial infarction within 6 months before the first dose of study drug
j) Received sotalol within 10 days of the first dose of treatment, or received a medication known to prolong the ECG QT interval within 14 days of the first dose of treatment
k) A heart rate of <50 or >100 bpm at rest on screening ECG
l) Patients aged more than 50 years should have a cardiac stress test
m) Note: Patients with history of coronary artery disease should have a thallium stress test and be cleared to participate in the study
Normal pulmonary function, which will be established as follows:
a) Patients aged less than 40 years without medical history of pulmonary disease: no testing
b) Patients aged more than 40 years, history of smoking, or pulmonary disease: determination of FEV (minimal FEV required: 75%)