A First-in-Human, Open-label, Phase Ia Dose Escalation Study of SON-DP in subjects with advanced/metastatic solid tumors that have relapsed or are refractory/intolerant to standard of care therapies
- Conditions
- Solid tumor malignanciesCancer - Any cancer
- Registration Number
- ACTRN12623000202662
- Lead Sponsor
- Qurgen Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 48
Phase 1a:
1.Participants are required to have:
a.Histological confirmed locally advanced or metastatic solid tumour, that is relapsed, refractory, or intolerant to currently approved therapies.
b.Measurable or evaluable disease by RECIST v1.1.
2.Willing and be able to understand and to sign an informed consent form (ICF) and to comply with all aspects of the protocol.
3.Female or male participants aged greater than or equal to 18 years.
4.Participants who use tobacco products can be included only if they agree that the use of nicotine- containing products (including nicotine patches) will not be permitted while they are in the study centre.
5.The ECOG performance status less than or equal to 1.
6.Life expectancy greater than 3 months in the Investigator’s opinion.
7.Participants must be candidates for and agree to the placement of a central venous access line and further must be able, in the opinion of the Investigator, to manage care of this line.
8.Participants with treated brain metastases are allowed but should be neurologically stable (for 4 weeks post-treatment as assessed by central nervous system (CNS) imaging and prior to study enrolment) and off steroids for at least 2 weeks before administration of any study treatment.
9.Adequate hepatic/renal function
10.Adequate haematological function
11.Coagulation tests within an acceptable range
1. Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
2.Presence of overt leptomeningeal or active CNS metastases or primary tumour or CNS metastases that require local CNS-directed therapy (e.g., radiotherapy or surgery) or increasing doses of corticosteroids within the prior 2 weeks.
3.Impaired cardiac function or clinically significant cardiac disease, including any of the following:
a.Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Grade greater or equal to 2), left ventricular ejection fraction (LVEF) less than 50% as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO), recorded in medical history of last two years or clinically significant arrhythmia.
b.QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than 470 ms ECG or congenital long QT syndrome at the Screening Visit.
c.Acute myocardial infarction or unstable angina pectoris less than 6 months prior to the first dose of study drug.
4.Uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and diastolic blood pressure greater than 100 mmHg), or in the opinion of the Investigator: a recent history of hypertension crisis, or a recent history of hypertensive encephalopathy.
5.History of stroke or clinically significant intracranial haemorrhage within 6 months before first dose of study drug.
6.Participants with active human immunodeficiency virus (HIV) infection or if subject has a history of HIV, subject must be confirmed to not have active infection.
7.Participants who have active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
8.Chronic liver disease or chronic hepatitis (Child-Pugh Class B or C hepatic impairment).
9.Prior or current malignant disease other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; adequately treated cervical carcinoma-in-situ completely resected basal cell or squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method