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CompletedPhase 1NCT05712889
Official study title

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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedVIP236 (Q3W) and VIP236 (Q2W)

The study team can explain what participation involves.

Who it may be forNeoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 15, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Vincerx Pharma, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Vincerx Pharma, Inc.
Interventions being studied
Drug: VIP236 (Q3W); Drug: VIP236 (Q2W)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Honor HealthScottsdale, Arizona
  • NEXT AustinAustin, Texas
  • NEXT Oncology San AntonioSan Antonio, Texas
  • Macquarie UniversityMacquarie Park, New South Wales
  • ICON BrisbaneBrisbane, Queensland
  • ICON AdelaideAdelaide, Southern Australia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 15, 2024. Always confirm current availability with the study team.

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