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Trial record 1 of 1 for:    vip236
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Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT05712889
Recruitment Status : Recruiting
First Posted : February 6, 2023
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Vincerx Pharma, Inc.

Study Description
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Brief Summary:
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer

Condition or disease Intervention/treatment Phase
Neoplasms Drug: VIP236 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
Actual Study Start Date : January 24, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation of VIP236
Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer
 Drug: VIP236
VIP236 will be administered by IV infusion once every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05712889


Contacts
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Contact: Vincerx Clinical Trials Contact 1-650-800-6676 clinicaltrials@vincerx.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Research Site         
United States, Texas
NEXT Austin Recruiting
Austin, Texas, United States, 78758
Contact: Research Site         
NEXT Oncology San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Research Site         
Australia, New South Wales
Macquarie University Recruiting
Macquarie Park, New South Wales, Australia, 2109
Contact: Research Site         
Australia, Queensland
ICON Brisbane Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Research Site         
Australia, Southern Australia
ICON Adelaide Recruiting
Adelaide, Southern Australia, Australia, 5037
Contact: Research Site         
Sponsors and Collaborators
Vincerx Pharma, Inc.
Investigators
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Study Director: Vincerx Study Director Vincerx Pharma, Inc.
More Information
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Responsible Party: Vincerx Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05712889    
Other Study ID Numbers: VNC-236-101
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincerx Pharma, Inc.:
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