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

NCT ID: NCT05712889

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2024-10-10

Brief Summary

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation of 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

Group Type: EXPERIMENTAL

VIP236 (Q3W)

Intervention Type: DRUG

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

Dose Escalation of 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.

Group Type: EXPERIMENTAL

VIP236 (Q2W)

Intervention Type: DRUG

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

Interventions

VIP236 (Q3W)

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

Intervention Type: DRUG

VIP236 (Q2W)

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

Intervention Type: DRUG

Eligibility Criteria

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. 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vincerx Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincerx Study Director

Role: STUDY_DIRECTOR

Vincerx Pharma, Inc.

Locations

Honor Health

Scottsdale, Arizona, United States

NEXT Austin

Austin, Texas, United States

NEXT Oncology San Antonio

San Antonio, Texas, United States

Macquarie University

Macquarie Park, New South Wales, Australia

ICON Brisbane

Brisbane, Queensland, Australia

ICON Adelaide

Adelaide, Southern Australia, Australia

Countries

United States; Australia

Other Identifiers

VNC-236-101

Identifier Type: -

Identifier Source: org_study_id