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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05712889




Registration number
NCT05712889
Ethics application status
Date submitted
25/01/2023
Date registered
6/02/2023
Date last updated
15/11/2024

Titles & IDs
Public title
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Scientific 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
Secondary ID [1] 0 0
VNC-236-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIP236 (Q3W)
Treatment: Drugs - VIP236 (Q2W)

Experimental: Dose Escalation of VIP236 (Q3W) - Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle

Experimental: Dose Escalation of VIP236 (Q2W) - Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 and D15 of each 28-day cycle.


Treatment: Drugs: VIP236 (Q3W)
VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.

Treatment: Drugs: VIP236 (Q2W)
VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of DLT (Dose limit toxicity) of VIP236
Timepoint [1] 0 0
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Primary outcome [2] 0 0
Number of participants with adverse events as a measure safety and tolerability
Timepoint [2] 0 0
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Secondary outcome [1] 0 0
Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1
Timepoint [1] 0 0
Up to 24 onths
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236
Timepoint [4] 0 0
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Secondary outcome [5] 0 0
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236
Timepoint [5] 0 0
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Eligibility
Key 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. Refer to NCCN guidelines 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2024
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,QLD,Southern Australi
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
ICON Brisbane - Brisbane
Recruitment hospital [3] 0 0
ICON Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
5037 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vincerx Pharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vincerx Study Director
Address 0 0
Vincerx Pharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vincerx Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
1-650-800-6676
Fax 0 0
Email 0 0
clinicaltrials@vincerx.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05712889