NCT05712889

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

January 25, 2023

Last Update Submit

November 13, 2024

Conditions

Neoplasms

Keywords

VIP236Solid tumorsBiliary tract cancerBreast cancerSmall cell lung cancerTriple negative breast cancerCervical cancerGastric cancerLung cancerNon-small cell lung cancerOvarian cancerPancreatic adenocarcinomaAdvanced solid tumorsMetastatic cancerEndometrial cancerUrothelial cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of DLT (Dose limit toxicity) of VIP236

    Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

  • Number of participants with adverse events as a measure safety and tolerability

    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 Outcomes (5)

  • 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

    Up to 24 onths

  • 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.

    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)

  • 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

    Up to 24 months

  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236

    Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

  • Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236

    Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Study Arms (2)

Dose Escalation of VIP236 (Q3W)

EXPERIMENTAL

Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle

Drug: VIP236 (Q3W)

Dose Escalation of VIP236 (Q2W)

EXPERIMENTAL

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.

Drug: VIP236 (Q2W)

Interventions

VIP236 (Q3W)DRUG

VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.

Dose Escalation of VIP236 (Q3W)
VIP236 (Q2W)DRUG

VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.

Dose Escalation of VIP236 (Q2W)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

NEXT Austin

Austin, Texas, 78758, United States

Location

NEXT Oncology San Antonio

San Antonio, Texas, 78229, United States

Location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

ICON Brisbane

Brisbane, Queensland, 4101, Australia

Location

ICON Adelaide

Adelaide, Southern Australia, 5037, Australia

Location

MeSH Terms

Conditions

NeoplasmsBiliary Tract NeoplasmsBreast NeoplasmsSmall Cell Lung CarcinomaTriple Negative Breast NeoplasmsUterine Cervical NeoplasmsStomach NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungOvarian NeoplasmsNeoplasm MetastasisEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincerx Study Director

    Vincerx Pharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 6, 2023

Study Start

January 24, 2023

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

AU(3)US(3)