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Trial Title:
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
NCT ID:
NCT05712889
Condition:
Neoplasms
Conditions: Keywords:
VIP236
Solid tumors
All comers
Breast cancer
Small cell lung cancer
Triple negative breast cancer
Colorectal cancer
Gastric cancer
Lung cancer
Non-small cell lung cancer
Renal cancer
Colon cancer
Advanced solid tumors
Metastatic cancer
Bladder cancer
Head and neck cancer
Esophageal cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VIP236
Description:
VIP236 will be administered by IV infusion once every 3 weeks.
Arm group label:
Dose Escalation of VIP236
Summary:
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered
VIP236 as monotherapy in patients with advanced solid tumor cancer
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Site
Facility:
Name:
NEXT Austin
Address:
City:
Austin
Zip:
78758
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Site
Facility:
Name:
NEXT Oncology San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Site
Facility:
Name:
Macquarie University
Address:
City:
Macquarie Park
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Research Site
Facility:
Name:
ICON Brisbane
Address:
City:
Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Research Site
Facility:
Name:
ICON Adelaide
Address:
City:
Adelaide
Zip:
5037
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Research Site
Start date:
January 24, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Vincerx Pharma, Inc.
Agency class:
Industry
Source:
Vincerx Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712889
