Neoplasms
Conditions
Keywords
VIP236, Solid tumors, Biliary tract cancer, Breast cancer, Small cell lung cancer, Triple negative breast cancer, Cervical cancer, Gastric cancer, Lung cancer, Non-small cell lung cancer, Ovarian cancer, Pancreatic adenocarcinoma, Advanced solid tumors, Metastatic cancer, Endometrial cancer, Urothelial cancer
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
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.
Interventions
DRUGVIP236 (Q3W)
VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.
DRUGVIP236 (Q2W)
VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.
Sponsors
Vincerx Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 28 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 28 days (up to approximately 10 months) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1 | Up to 24 onths |
| 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 28 days |
| 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 28 days |
| 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 28 days (up to approximately 10 months) |
Countries
Australia, United States
Outcome results
None listed