Phase
Condition
Neoplasms
Treatment
VIP236 (Q2W)
VIP236
VIP236 (Q3W)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients aged >/=18 years, able to provide informed consent and willing tocomply with all study procedures.
Histologically confirmed advanced or metastatic solid tumors that are relapsed orrefractory to standard of care. Subjects must have exhausted all available standardtherapies or be deemed ineligible for potential available therapies. Refer to NCCNguidelines of each respective histology for guidance. Starting with Amendment 3,this study will focus enrollment on the following cancers:
Biliary tract cancers Breast cancer Cervical cancer Endometrial carcinoma Gastric cancer/gastroesophageal junction adenocarcinoma Nonsmall cell lung cancer Ovarian cancer/fallopian tube cancer/primary peritoneal cancer Pancreatic adenocarcinoma Small cell lung cancer Urothelial cancer
Adequate bone marrow, liver, and renal functions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion
Exclusion Criteria:
Subjects who have new or progressive brain or meningeal or spinal metastases.
Clinically significant cardiac disease including congestive heart failure > New YorkHeart Association (NYHA) Class II), evidence for coronary artery disease (eg,unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6months or myocardial infarction within the past 6 months before first dose.
Major surgery or significant trauma within 4 weeks before the first dose of studydrug.
Medical history of chronic obstructive pulmonary disease (COPD) and otherrespiratory disorders.
Study Design
Study Description
Connect with a study center
Macquarie University
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
ICON Brisbane
Brisbane, Queensland 4101
AustraliaSite Not Available
ICON Adelaide
Adelaide, Southern Australia 5037
AustraliaSite Not Available
Honor Health
Scottsdale, Arizona 85258
United StatesSite Not Available
NEXT Austin
Austin, Texas 78758
United StatesSite Not Available
NEXT Oncology San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
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