NeoplasmsPhase 1NCT05712889
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
A Phase 1 study testing VIP236 (Q3W) and VIP236 (Q2W) in people with Neoplasms, run by Vincerx Pharma, Inc. at 6 sites in 2 countries.
Trial summary
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- VIP236 (Q3W) and VIP236 (Q2W)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 24 Jan 2023to 10 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
NEXT Austin
Austin, Texas, 78758
NEXT Oncology San Antonio
San Antonio, Texas, 78229
Honor Health
Scottsdale, Arizona, 85258
Australia3 sites
ICON Adelaide
Adelaide, Southern Australia, 5037
ICON Brisbane
Brisbane, Queensland, 4101
Macquarie University
Macquarie Park, New South Wales, 2109
About this study
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
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
Read the detailed description
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.
- Conditions
- Neoplasms
- Being tested
- VIP236 (Q3W), VIP236 (Q2W)
- Keywords
- VIP236, Solid tumors, Biliary tract cancer, Breast cancer, Small cell lung cancer, Triple negative breast cancer, Cervical cancer, Gastric cancer, Lung cancer, Non-small cell lung cancer, Ovarian cancer, Pancreatic adenocarcinoma, Advanced solid tumors, Metastatic cancer, Endometrial cancer, Urothelial cancer
- Medical subject headings
- Neoplasms, Biliary Tract Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP236 (Q3W)Drug
VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.
VIP236 (Q2W)Drug
VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: VIP236 (Q2W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT (Dose limit toxicity) of VIP236
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 24 months
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236
Measured: 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
Measured: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start24 Jan 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincerx Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincerx Study Director, Study director, Vincerx Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712889
- Sponsor's protocol ID
- VNC-236-101
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05712889
- Acronym / sponsor ID
- VNC-236-101
- Conditions
- Neoplasms
- Keywords
- VIP236, Solid tumors, Biliary tract cancer, Breast cancer, Small cell lung cancer, Triple negative breast cancer, Cervical cancer, Gastric cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vincerx Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
Detailed description
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of VIP236 (Q3W) | Experimental | Drug: 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 |
| Dose Escalation of VIP236 (Q2W) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIP236 (Q3W)VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle. | Drug | Dose Escalation of VIP236 (Q3W) |
| VIP236 (Q2W)VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle. | Drug | Dose Escalation of VIP236 (Q2W) |
Primary outcome
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 28 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 28 days (up to approximately 10 months)
5 secondary outcomes
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
Time frame: 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.
Time frame: 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
Time frame: 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 28 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 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincerx Study Director study director
Vincerx Pharma, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIP236 (Q3W) and VIP236 (Q2W) in people with Neoplasms, run by Vincerx Pharma, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.