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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: VIP236 (Q3W); Drug: VIP236 (Q2W)

• Registration Number: NCT05712889
• Lead Sponsor: Vincerx Pharma, Inc.

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.

Study Timeline

• Study Start: 2023-01-24
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-06
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation of VIP236 (Q3W)	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
Dose Escalation of VIP236 (Q2W)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of DLT (Dose limit toxicity) of VIP236	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	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 Outcome Measures

Name	Time	Method
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	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.	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	Up to 24 months
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236	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	Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days

Trial Locations

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

ICON Brisbane; 🇦🇺 Brisbane, Queensland, Australia

ICON Adelaide; 🇦🇺 Adelaide, Southern Australia, Australia