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

Neoplasms Clinical Trial

Official title:

An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712889
• Other study ID #: VNC-236-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Vincerx Pharma, Inc.
• Contact: Vincerx Clinical Trials Contact
• Phone: 1-650-800-6676
• Email: clinicaltrials[@]vincerx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

All comers 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• 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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• VIP236
VIP236 will be administered by IV infusion once every 3 weeks.

Locations

Country	Name	City	State
Australia	ICON Adelaide	Adelaide	Southern Australia
Australia	ICON Brisbane	Brisbane	Queensland
Australia	Macquarie University	Macquarie Park	New South Wales
United States	NEXT Austin	Austin	Texas
United States	NEXT Oncology San Antonio	San Antonio	Texas
United States	Honor Health	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vincerx Pharma, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLT (Dose limit toxicity) of VIP236		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	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 21 days (up to approximately 10 months)
Secondary	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 21 days (up to approximately 10 months)
Secondary	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
Secondary	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 21 days
Secondary	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 21 days