VNC-236-101


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

Trial summary:

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

Receptor status / problem studied:

Inclusion criteria

1) Adult patients aged >/=18 years, able to provide informed consent and willing to comply with all study procedures.

2) 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.

3) Adequate bone marrow, liver, and renal functions.

4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion criteria

1) Subjects who have new or progressive brain or meningeal or spinal metastases.

2) 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.

3) Major surgery or significant trauma within 4 weeks before the first dose of study drug.

4) Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.

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Trial on hold

Trial Title

VNC-236-101

Diagnosis

Advanced solid tumours

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

I

Investigators

Principal Investigator
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