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

Vincerx Pharma

Status and phase

Enrolling

Phase 1

Conditions

Neoplasms

Treatments

Drug: VIP236

Study type

Interventional

Funder types

Industry

Identifiers

NCT05712889

VNC-236-101

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.