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Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer

PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-01-24

Primary completion: 2024-03-01

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05712889

Intervention or treatment

DRUG: VIP236

Conditions

• Neoplasms

Condition: Neoplasms
DRUG: VIP236
Macquarie Park, New South Wales, Australia and more
Sponsor: Vincerx Pharma, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Macquarie University

Research sites nearby

Select from list below to view details:

Macquarie University
Macquarie Park, New South Wales, Australia
ICON Brisbane
Brisbane, Queensland, Australia
ICON Adelaide
Adelaide, Southern Australia, Australia

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?

Participant Group/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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of DLT (Dose limit toxicity) of VIP236	Not Specified	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	Not Specified	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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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.	Not Specified	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	Not Specified	Up to 24 months
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236	Not Specified	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	Not Specified	Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer