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

Vincerx Pharma

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: VIP236 (Q3W); Drug: VIP236 (Q2W)

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

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: 29 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. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Dose Escalation of VIP236 (Q3W)

Experimental group

Description:

Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle

Treatment:

Drug: VIP236 (Q3W)

Dose Escalation of VIP236 (Q2W)

Experimental group

Description:

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.

Treatment:

Drug: VIP236 (Q2W)