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

Study Overview
=================
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
-----------------
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.

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

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: VIP236


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation of VIP236<br>Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer | Drug: VIP236<br>* VIP236 will be administered by IV infusion once every 3 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 21 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 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VIP236, Solid tumors, All comers, Breast cancer, Small cell lung cancer, Triple negative breast cancer, Colorectal cancer, Gastric cancer, Lung cancer, Non-small cell lung cancer, Renal cancer, Colon cancer, Advanced solid tumors, Metastatic cancer, Bladder cancer, Head and neck cancer, Esophageal cancer