Colon Cancer Clinical Trial
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Summary
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
Full Description
All comers solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
Eligibility Criteria
Inclusion Criteria:
Adult patients aged >/=18 years, able to provide informed consent and willing to comply with all study procedures.
Histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
Adequate bone marrow, liver, and renal functions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
Subjects who have new or progressive brain or meningeal or spinal metastases.
Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
Major surgery or significant trauma within 4 weeks before the first dose of study drug.
Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.
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There are 6 Locations for this study
Macquarie Park New South Wales, 2109, Australia More Info
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