- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712889
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
January 10, 2024 updated by: Vincerx Pharma, Inc.
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincerx Clinical Trials Contact
- Phone Number: 1-650-800-6676
- Email: clinicaltrials@vincerx.com
Study Locations
-
-
New South Wales
-
Macquarie Park, New South Wales, Australia, 2109
- Recruiting
- Macquarie University
-
Contact:
- Research Site
-
-
Queensland
-
Brisbane, Queensland, Australia, 4101
- Recruiting
- ICON Brisbane
-
Contact:
- Research Site
-
-
Southern Australia
-
Adelaide, Southern Australia, Australia, 5037
- Recruiting
- ICON Adelaide
-
Contact:
- Research Site
-
-
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Recruiting
- Honor Health
-
Contact:
- Research Site
-
-
Texas
-
Austin, Texas, United States, 78758
- Recruiting
- NEXT Austin
-
Contact:
- Research Site
-
San Antonio, Texas, United States, 78229
- Recruiting
- NEXT Oncology San Antonio
-
Contact:
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation of VIP236
Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer
|
VIP236 will be administered by IV infusion once every 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of DLT (Dose limit toxicity) of VIP236
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Number of participants with adverse events as a measure safety and tolerability
Time Frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 10 months)
|
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 10 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.
Time Frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 10 months)
|
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 10 months)
|
Progression-free survival per RECIST v1.1, defined as the time from enrollment to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review
Time Frame: Up to 24 months
|
Up to 24 months
|
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Vincerx Study Director, Vincerx Pharma, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
January 25, 2023
First Submitted That Met QC Criteria
January 25, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VNC-236-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
GlaxoSmithKlineRecruitingColonic Neoplasms | Neoplasms, ColonUnited States, Finland, France, Italy, Japan, Netherlands, Norway, Spain, Taiwan, United Kingdom, Australia, Belgium, Brazil, Germany, Greece, Sweden, Turkey, Canada, Korea, Republic of, Argentina, Hungary, Estonia, Portugal, Mexico, Pa...
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong