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

Vincerx Pharma, Inc.29 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

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)

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

Data from ClinicalTrials.gov

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