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

Last updated: November 13, 2024
Sponsor: Vincerx Pharma, Inc.
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

VIP236 (Q2W)

VIP236

VIP236 (Q3W)

Clinical Study ID

NCT05712889
VNC-236-101
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients aged >/=18 years, able to provide informed consent and willing tocomply with all study procedures.

  • Histologically confirmed advanced or metastatic solid tumors that are relapsed orrefractory to standard of care. Subjects must have exhausted all available standardtherapies or be deemed ineligible for potential available therapies. Refer to NCCNguidelines 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.

Exclusion

Exclusion Criteria:

  • Subjects who have new or progressive brain or meningeal or spinal metastases.

  • Clinically significant cardiac disease including congestive heart failure > New YorkHeart Association (NYHA) Class II), evidence for coronary artery disease (eg,unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6months or myocardial infarction within the past 6 months before first dose.

  • Major surgery or significant trauma within 4 weeks before the first dose of studydrug.

  • Medical history of chronic obstructive pulmonary disease (COPD) and otherrespiratory disorders.

Study Design

Total Participants: 29
Treatment Group(s): 3
Primary Treatment: VIP236 (Q2W)
Phase: 1
Study Start date:
January 24, 2023
Estimated Completion Date:
October 10, 2024

Study 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.

Connect with a study center

  • Macquarie University

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • ICON Brisbane

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • ICON Adelaide

    Adelaide, Southern Australia 5037
    Australia

    Site Not Available

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • NEXT Austin

    Austin, Texas 78758
    United States

    Site Not Available

  • NEXT Oncology San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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